Comparison of Inhaled Oxytocin (IH) With Intramuscular (IM) Oxytocin in Pregnant Women and With Intravenous (IV) Oxytocin in Healthy Non-pregnant Women

A Randomized, Open-label Study to Characterize the Pharmacokinetics of Inhaled Oxytocin (GR121619) Compared With IM Oxytocin in Women in the Third Stage of Labour, and With IV Oxytocin in Non-pregnant, Non-lactating Women of Childbearing Potential

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02999100

Enrollment

Registered

2016-12-21

Start date

2016-11-23

Completion date

2019-03-04

Last updated

2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Hemorrhage

Keywords

oxytocin, non-pregnant, pregnant, Postpartum Hemorrhage

Brief summary

The study will evaluate a stable, dry-powder formulation of oxytocin, with the goal of reducing post-partum hemorrhage morbidity and mortality in resource poor settings. This study is being conducted to further assess safety and tolerability of inhaled oxytocin, and to characterize the drug levels of inhaled (IH) oxytocin when compared to oxytocin administered as standard of care. Two groups of subjects will be enrolled. Group 1 will enroll pregnant women, who will be randomized to receive either IH or intramuscular (IM) oxytocin as active management of the third stage of labour (after the baby is born). Group 2 will enroll non-pregnant women of childbearing potential, who will receive IH oxytocin and intravenous (IV) oxytocin in a cross over design over two dosing sessions This group will evaluate the safety and tolerability of IH and IV oxytocin.

Interventions

DRUGIH Oxytocin

Oxytocin will be supplied as colourless and clear hard capsule with powder blend for inhalation with unit dose strength 400 mcg and 200 mcg. It will be administered using ROTAHALER dry powder inhaler (DPI).

DRUGIM Oxytocin

Oxytocin will be supplied for solution for infusion in 1ml ampoule containing colourless and clear sterile solution with unit dose strength 5 I.U./mL, or 10 I.U./mL for IM administration

DRUGIV Oxytocin

Oxytocin will be supplied as solution for infusion in 1ml ampoule containing colourless and clear sterile solution to be administered as a 30-second IV bolus with unit dose strength 5 I.U./mL, or 10 I.U./mL.

DEVICEROTAHALER

ROTAHALER DPI device is a high airflow resistance capsule-based inhaler. It will be used to deliver IH oxytocin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

All Groups: * Between 18 and 40 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, and laboratory tests as required per protocol. * Subject clinical chemistry and haematology values within an acceptable range for the population recruited and not of abnormal clinical significance. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or

Exclusion criteria

, outside the reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor (if required) agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * Adequate peripheral venous access for cannulation. Group 1 Only: * Currently pregnant, with an uncomplicated pregnancy as determined by the investigator or designee. * Estimated date of delivery within 24 weeks of screening. * Planned spontaneous vaginal birth and considered by investigator at low risk for post partum hemorrhage (PPH). * Planned birth in between the 37th and 42nd week of pregnancy. * Women who qualify for oxytocin as appropriate for active management of TSL and who agree to have active management. Group 2 Only: * ECG normal, or abnormal and not clinically significant. * FEV1 \>80% of predicted. * Systolic blood pressure \>=90 millimeters of mercury (mmHg). * Body mass index (BMI) within the range 18 - 32 Kilogram (kg)/square meter (m\^2) (inclusive). * Sex-Female. * Group 2, Cohort A Only: A female subject is eligible to participate if she is confirmed to be not pregnant at screening and on Day 1 (as confirmed by a negative serum or urine human chorionic gonadotrophin \[hCG\] test), not lactating, and the following condition applies: Is of reproductive potential and agrees to use the same combined estrogen and progestogen oral contraceptive from 3 months prior to the first dose of study medication and until the follow-up contact. This method of contraception is only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use their method of contraception * Group 2, Cohort B Only: A female subject is eligible to participate if she is confirmed to be not pregnant at screening and on Day 1 (as confirmed by a negative serum or urine hCG test), not lactating, and one of the following conditions applies: Is of reproductive potential and has been using the same non-hormonal contraceptive method from 3 months prior to the first dose of study medication and until the follow-up contact. Would be of reproductive potential, but has undergone bilateral tubal ligation or occlusion or bilateral salpingectomy at least 12 months prior to first dose of study medication. Is of reproductive potential with only same sex partners or who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis, when this is their preferred and usual lifestyle. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. These methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use their method(s) of contraception. Of Note: Group 2, Cohort B will enrol women of reproductive potential if they agree to use a nonhormonal contraceptive method from at least one month prior to receiving study drug and until the follow-up assessment. Although condoms with spermicide are not considered a highly effective method of contraception, the risk of receiving study drug during pregnancy is minimal for the following reasons: Pregnancy testing must be negative at screening and on the first day of dosing. Dosing is completed no greater than 14 days from the start of dosing. Oxytocin has a well established rapid half-life. If a patient happened to conceive during the time of dosing, study drug would be eliminated before implantation would occur. * All Groups: Capable of giving signed informed consent as described in Protocol which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.

Design outcomes

Primary

Measure	Time frame	Description
Part 2: Time to Reach Terminal Phase Half-life (t1/2) of Oxytocin	-1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose	Blood samples were collected at indicated time points to evaluate t1/2 of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Part 2: Absolute Values of Respiration Rate	Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post-dose	Respiration rate was measured in semi-supine position after 5 minutes rest
Part 2: Plasma Concentration Time Profile of Oxytocin.	-1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose	Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Part 2: Maximum Observed Plasma Concentration (Cmax) of Oxytocin	-1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose	Blood samples were collected at indicated time points to evaluate Cmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Part 2: Observed Plasma Concentration (Cp)10 of Oxytocin	10 minutes post dose	Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Part 2: Observed Plasma Concentration (Cp)20 of Oxytocin	20 minutes post dose	Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Part 2: Observed Plasma Concentration (Cp)30 of Oxytocin	30 minutes post dose	Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Part 2: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin	-1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose	Blood samples were collected at indicated time points to evaluate Tmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Part 2: Plasma Clearance (CL) of Oxytocin for IV Route Only	-1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose	Blood samples were collected at indicated time points to evaluate plasma clearance of oxytocin IV bolus and infusion. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Part 2: Area Under the Concentration-time Curve From Time Zero Extrapolated to Time 't' (AUC[0-t]) of Oxytocin	-1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose	Blood samples were collected at indicated time points to evaluate AUC (0-t) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Part 2: Volume of Distribution (VOD) of Oxytocin for IV Route Only	-1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose	Blood samples were collected at indicated time points to evaluate volume of distribution of oxytocin IV bolus and infusion. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Part 1: Plasma Concentration Time Profile of Oxytocin	Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1	Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Part 1: Maximum Observed Plasma Concentration (Cmax) of Oxytocin	Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1	Blood samples were collected at indicated time points to evaluate Cmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Part 1: Observed Plasma Concentration (Cp) 10 of Oxytocin	10 minutes post dose Day 1	Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Part 1: Observed Plasma Concentration (Cp) 20 of Oxytocin	20 minutes post dose Day 1	Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Part 1: Observed Plasma Concentration (Cp) 30 of Oxytocin	30 minutes post dose Day 1	Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin	Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1	Blood samples were collected at indicated time points to evaluate Tmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Part 1: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Oxytocin	Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose on Day 1	Blood samples were collected at indicated time points to evaluate AUC (0-t) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Part 1: Terminal Phase Half-life (t1/2) of Oxytocin	Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose on Day 1	Blood samples were collected at indicated time points to evaluate t1/2 of oxytocin.
Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)	Up to 37 days	An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. As SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety Population includes participants who received at least one dose of study medication.
Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose	Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
Part 2: Change From Baseline in SBP and DBP	Baseline (Day 1, pre-dose), 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose	SBP and DBP of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Part 2: Change From Baseline in Heart Rate	Baseline (Day 1, pre-dose), 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose	Heart rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Part 2: Absolute Values of Heart Rate	Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose	Heart rate was measured in semi-supine position after 5 minutes rest
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	Pre-dose, 2 minutes, 10 minutes, 20 minutes, 30 minutes, 1 hour and 4 hours post dose	Triplicate 12-lead electrocardiograms (ECGs) were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measured PR interval, QRS duration, QTcB interval, and QTcF interval.
Part 2: Number of Participants With Abnormal Respiratory Events	Up to Day 37	Number of participants with abnormal respiratory events has been presented
Part 2: Forced Expiratory Volume at 1 Minute (FEV1)	Pre dose and 1 hour post dose on Day1	FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements were taken electronically by spirometry on Day 1. At each time point, three best measurements were recorded.
Part 2: Percent Oxygen in Blood	Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post-dose	Percent oxygen in blood was measured using pulse oximetry in a semi-supine position after 5 minutes rest. Pulse oximeter is a device that measures oxygen saturation of arterial blood in participants by utilizing a sensor attached typically to a finger, toe, or ear to determine the percentage of oxyhemoglobin in blood pulsating through a network of capillaries

Secondary

Measure	Time frame	Description
Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	30 minutes and 2 hours post dose	Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
Part 1: Absolute Values of Heart Rate	30 minutes and 2 hours post dose	Heart rate was measured in semi-supine position after 5 minutes rest
Part 1: Absolute Values of Respiration Rate	30 minutes and 2 hours post dose	Respiration rate was measured in semi-supine position after 5 minutes rest
Part 1: Absolute Values of Temperature	30 minutes and 2 hours post dose	Body temperature was measured in semi-supine position after 5 minutes rest
Part 1: Change From Baseline in SBP and DBP	Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose	SBP and DBP of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Part 1: Change From Baseline in Heart Rate	Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose	Heart rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Part 1: Change From Baseline in Respiration Rate	Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose	Respiration rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Part 1: Change From Baseline in Body Temperature	Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose	Body temperature was measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Three Hours (AUC ([0-3]) of Oxytocin	Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours and 3 hours post dose on Day 1	Blood samples were collected at indicated time points to evaluate AUC (0-3) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Part 1: Number of Participants With Non-SAEs and SAEs	Up to 15 days	An adverse event is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function.

Countries

Australia, United Kingdom

Participant flow

Recruitment details

This is a 2 part study: Part 1 enrolled pregnant women, randomized to receive either inhaled (IH) or intramuscular (IM) oxytocin as active management of the third stage of labor. Part 2 enrolled non-pregnant women of childbearing potential and received IH oxytocin and intravenous (IV) oxytocin in a cross over design.

Pre-assignment details

A total of 31 participants were enrolled in the study. This study was terminated due to inability to reliably measure plasma oxytocin levels in women in third stage labor, regardless of administration method (IH, IM or IV).

Participants by arm

Arm	Count
400 mcg Oxytocin IH Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labor (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	9
17 mcg Oxytocin IM Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	8
Contraceptives+400 mcg Oxytocin IH, Then 8.5mcg Oxytocin IV Healthy participants of childbearing potential were administered oral contraceptive along with 400 mcg oxytocin IH during Session 1 and received 8.5 mcg oxytocin IV during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.	5
Contraceptives+8.5mcg Oxytocin IV, Then 400 mcg Oxytocin IH Healthy participants of childbearing potential were administered oral contraceptives along with 8.5 mcg oxytocin IV during Session 1 and received 400 mcg oxytocin IH during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.	3
400 mcg Oxytocin IH, Then 8.5 mcg Oxytocin IV Healthy participants of childbearing potential were administered 400 mcg oxytocin IH during Session 1 and received 8.5 mcg oxytocin IV during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.	3
8.5 mcg Oxytocin IV, Then 400 mcg Oxytocin IH Healthy participants of childbearing potential were administered 8.5 mcg oxytocin IV during Session 1 and received 400 mcg oxytocin IH during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.	3
Total	31

Withdrawals & dropouts

Period	Reason	FG001	FG002	FG005
Part 1 (up to 15 Days)	Adverse Event	1	0	0
Part 2 (Day 1): Dosing Session 1	Protocol Violation	0	1	0
Part 2 (Day 1): Dosing Session 1	Withdrawal by Subject	0	0	1

Baseline characteristics

Characteristic	400 mcg Oxytocin IH	17 mcg Oxytocin IM	Contraceptives+400 mcg Oxytocin IH, Then 8.5mcg Oxytocin IV	Contraceptives+8.5mcg Oxytocin IV, Then 400 mcg Oxytocin IH	400 mcg Oxytocin IH, Then 8.5 mcg Oxytocin IV	8.5 mcg Oxytocin IV, Then 400 mcg Oxytocin IH	Total
Age, Continuous	31.8 Years STANDARD_DEVIATION 3.49	28.1 Years STANDARD_DEVIATION 5.84	24.0 Years STANDARD_DEVIATION 4.53	30.7 Years STANDARD_DEVIATION 0.58	37.3 Years STANDARD_DEVIATION 1.53	27.7 Years STANDARD_DEVIATION 6.66	29.6 Years STANDARD_DEVIATION 5.55
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Race/Ethnicity, Customized Mixed race	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	7 Participants	5 Participants	4 Participants	3 Participants	3 Participants	3 Participants	25 Participants
Sex: Female, Male Female	9 Participants	8 Participants	5 Participants	3 Participants	3 Participants	3 Participants	31 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk
deaths Total, all-cause mortality	0 / 9	0 / 8	0 / 7	0 / 5	0 / 2	0 / 5	0 / 1	0 / 5
other Total, other adverse events	3 / 9	2 / 8	7 / 7	5 / 5	1 / 2	3 / 5	1 / 1	5 / 5
serious Total, serious adverse events	2 / 9	2 / 8	0 / 7	0 / 5	0 / 2	0 / 5	0 / 1	0 / 5

Outcome results

Primary

Part 1: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Oxytocin

Blood samples were collected at indicated time points to evaluate AUC (0-t) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Time frame: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose on Day 1

Population: Pharmacokinetic Population.

Arm	Measure	Value (MEDIAN)
400 mcg Oxytocin IH	Part 1: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Oxytocin	NA Hour*picogram per milliliter
17 mcg Oxytocin IM	Part 1: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Oxytocin	NA Hour*picogram per milliliter

Primary

Part 1: Maximum Observed Plasma Concentration (Cmax) of Oxytocin

Blood samples were collected at indicated time points to evaluate Cmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Time frame: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1

Population: Pharmacokinetic Population.

Arm	Measure	Value (MEDIAN)
400 mcg Oxytocin IH	Part 1: Maximum Observed Plasma Concentration (Cmax) of Oxytocin	2.460 Picograms per milliliter
17 mcg Oxytocin IM	Part 1: Maximum Observed Plasma Concentration (Cmax) of Oxytocin	NA Picograms per milliliter

Primary

Part 1: Observed Plasma Concentration (Cp) 10 of Oxytocin

Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Time frame: 10 minutes post dose Day 1

Population: Pharmacokinetic Population.

Arm	Measure	Value (MEDIAN)
400 mcg Oxytocin IH	Part 1: Observed Plasma Concentration (Cp) 10 of Oxytocin	NA Picogram per milliliter
17 mcg Oxytocin IM	Part 1: Observed Plasma Concentration (Cp) 10 of Oxytocin	NA Picogram per milliliter

Primary

Part 1: Observed Plasma Concentration (Cp) 20 of Oxytocin

Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Time frame: 20 minutes post dose Day 1

Population: Pharmacokinetic Population.

Arm	Measure	Value (MEDIAN)
400 mcg Oxytocin IH	Part 1: Observed Plasma Concentration (Cp) 20 of Oxytocin	NA Picogram per milliliter
17 mcg Oxytocin IM	Part 1: Observed Plasma Concentration (Cp) 20 of Oxytocin	1.960 Picogram per milliliter

Primary

Part 1: Observed Plasma Concentration (Cp) 30 of Oxytocin

Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Time frame: 30 minutes post dose Day 1

Population: Pharmacokinetic Population.

Arm	Measure	Value (MEDIAN)
400 mcg Oxytocin IH	Part 1: Observed Plasma Concentration (Cp) 30 of Oxytocin	NA Picogram per milliliter
17 mcg Oxytocin IM	Part 1: Observed Plasma Concentration (Cp) 30 of Oxytocin	NA Picogram per milliliter

Primary

Part 1: Plasma Concentration Time Profile of Oxytocin

Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Time frame: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1

Population: Pharmacokinetic Population includes all participants in Safety population for whom a pharmacokinetic sample was obtained \& analysed.Safety Population includes participants who received at least one dose of study medication.Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles)

Arm	Measure	Group	Value (MEDIAN)
400 mcg Oxytocin IH	Part 1: Plasma Concentration Time Profile of Oxytocin	20 minutes post dose; n=8, 6	0.000 Picograms per milliliter
400 mcg Oxytocin IH	Part 1: Plasma Concentration Time Profile of Oxytocin	5 minutes post dose; n=8, 7	1.020 Picograms per milliliter
400 mcg Oxytocin IH	Part 1: Plasma Concentration Time Profile of Oxytocin	1 hour post dose; n=8, 7	0.000 Picograms per milliliter
400 mcg Oxytocin IH	Part 1: Plasma Concentration Time Profile of Oxytocin	10 minutes post dose; n=7, 8	0.000 Picograms per milliliter
400 mcg Oxytocin IH	Part 1: Plasma Concentration Time Profile of Oxytocin	2 hours post dose; n=9, 7	0.000 Picograms per milliliter
400 mcg Oxytocin IH	Part 1: Plasma Concentration Time Profile of Oxytocin	15 minutes post dose; n=8, 8	0.000 Picograms per milliliter
400 mcg Oxytocin IH	Part 1: Plasma Concentration Time Profile of Oxytocin	2.5 hours post dose; n=9, 7	0.000 Picograms per milliliter
400 mcg Oxytocin IH	Part 1: Plasma Concentration Time Profile of Oxytocin	Pre-dose; n=9, 8	0.000 Picograms per milliliter
400 mcg Oxytocin IH	Part 1: Plasma Concentration Time Profile of Oxytocin	3 hours post dose; n=8, 7	0.000 Picograms per milliliter
400 mcg Oxytocin IH	Part 1: Plasma Concentration Time Profile of Oxytocin	30 minutes post dose; n=8, 7	0.000 Picograms per milliliter
400 mcg Oxytocin IH	Part 1: Plasma Concentration Time Profile of Oxytocin	4 hours post dose; n=8, 7	0.000 Picograms per milliliter
400 mcg Oxytocin IH	Part 1: Plasma Concentration Time Profile of Oxytocin	3 minutes post dose; n= 7, 7	0.000 Picograms per milliliter
17 mcg Oxytocin IM	Part 1: Plasma Concentration Time Profile of Oxytocin	4 hours post dose; n=8, 7	0.000 Picograms per milliliter
17 mcg Oxytocin IM	Part 1: Plasma Concentration Time Profile of Oxytocin	15 minutes post dose; n=8, 8	0.000 Picograms per milliliter
17 mcg Oxytocin IM	Part 1: Plasma Concentration Time Profile of Oxytocin	20 minutes post dose; n=8, 6	0.000 Picograms per milliliter
17 mcg Oxytocin IM	Part 1: Plasma Concentration Time Profile of Oxytocin	30 minutes post dose; n=8, 7	0.000 Picograms per milliliter
17 mcg Oxytocin IM	Part 1: Plasma Concentration Time Profile of Oxytocin	1 hour post dose; n=8, 7	0.000 Picograms per milliliter
17 mcg Oxytocin IM	Part 1: Plasma Concentration Time Profile of Oxytocin	Pre-dose; n=9, 8	0.000 Picograms per milliliter
17 mcg Oxytocin IM	Part 1: Plasma Concentration Time Profile of Oxytocin	3 minutes post dose; n= 7, 7	0.000 Picograms per milliliter
17 mcg Oxytocin IM	Part 1: Plasma Concentration Time Profile of Oxytocin	5 minutes post dose; n=8, 7	0.000 Picograms per milliliter
17 mcg Oxytocin IM	Part 1: Plasma Concentration Time Profile of Oxytocin	2 hours post dose; n=9, 7	0.000 Picograms per milliliter
17 mcg Oxytocin IM	Part 1: Plasma Concentration Time Profile of Oxytocin	2.5 hours post dose; n=9, 7	0.000 Picograms per milliliter
17 mcg Oxytocin IM	Part 1: Plasma Concentration Time Profile of Oxytocin	3 hours post dose; n=8, 7	0.000 Picograms per milliliter
17 mcg Oxytocin IM	Part 1: Plasma Concentration Time Profile of Oxytocin	10 minutes post dose; n=7, 8	0.000 Picograms per milliliter

Primary

Part 1: Terminal Phase Half-life (t1/2) of Oxytocin

Blood samples were collected at indicated time points to evaluate t1/2 of oxytocin.

Time frame: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose on Day 1

Population: Pharmacokinetic Population.

Arm	Measure	Value (MEDIAN)
400 mcg Oxytocin IH	Part 1: Terminal Phase Half-life (t1/2) of Oxytocin	NA Hours
17 mcg Oxytocin IM	Part 1: Terminal Phase Half-life (t1/2) of Oxytocin	NA Hours

Primary

Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin

Blood samples were collected at indicated time points to evaluate Tmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Time frame: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Arm	Measure	Value (MEDIAN)
400 mcg Oxytocin IH	Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin	0.15000 Hours
17 mcg Oxytocin IM	Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin	0.25000 Hours

Primary

Part 2: Absolute Values of Heart Rate

Heart rate was measured in semi-supine position after 5 minutes rest

Time frame: Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose

Population: Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Arm	Measure	Group	Value (MEAN)	Dispersion
400 mcg Oxytocin IH	Part 2: Absolute Values of Heart Rate	Pre dose	71.1 Beats per minute	Standard Deviation 15.29
400 mcg Oxytocin IH	Part 2: Absolute Values of Heart Rate	15 minutes	74.0 Beats per minute	Standard Deviation 10.31
400 mcg Oxytocin IH	Part 2: Absolute Values of Heart Rate	4 hours	74.3 Beats per minute	Standard Deviation 13.21
400 mcg Oxytocin IH	Part 2: Absolute Values of Heart Rate	5 minutes	74.0 Beats per minute	Standard Deviation 15.01
400 mcg Oxytocin IH	Part 2: Absolute Values of Heart Rate	30 minutes	69.3 Beats per minute	Standard Deviation 9.32
400 mcg Oxytocin IH	Part 2: Absolute Values of Heart Rate	1 hour	65.3 Beats per minute	Standard Deviation 10.59
17 mcg Oxytocin IM	Part 2: Absolute Values of Heart Rate	Pre dose	65.2 Beats per minute	Standard Deviation 5.93
17 mcg Oxytocin IM	Part 2: Absolute Values of Heart Rate	30 minutes	66.4 Beats per minute	Standard Deviation 6.47
17 mcg Oxytocin IM	Part 2: Absolute Values of Heart Rate	1 hour	67.4 Beats per minute	Standard Deviation 4.67
17 mcg Oxytocin IM	Part 2: Absolute Values of Heart Rate	15 minutes	69.6 Beats per minute	Standard Deviation 5.64
17 mcg Oxytocin IM	Part 2: Absolute Values of Heart Rate	4 hours	71 Beats per minute	Standard Deviation 5.7
17 mcg Oxytocin IM	Part 2: Absolute Values of Heart Rate	5 minutes	79 Beats per minute	Standard Deviation 8.15
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Heart Rate	4 hours	72.5 Beats per minute	Standard Deviation 0.71
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Heart Rate	5 minutes	83 Beats per minute	Standard Deviation 18.38
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Heart Rate	1 hour	68 Beats per minute	Standard Deviation 15.56
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Heart Rate	30 minutes	64.5 Beats per minute	Standard Deviation 23.33
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Heart Rate	15 minutes	70.5 Beats per minute	Standard Deviation 14.85
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Heart Rate	Pre dose	63.5 Beats per minute	Standard Deviation 21.92
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Heart Rate	5 minutes	72.4 Beats per minute	Standard Deviation 14.1
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Heart Rate	Pre dose	65 Beats per minute	Standard Deviation 9.3
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Heart Rate	30 minutes	61.4 Beats per minute	Standard Deviation 7.96
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Heart Rate	4 hours	71.2 Beats per minute	Standard Deviation 5.54
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Heart Rate	15 minutes	67.6 Beats per minute	Standard Deviation 11.93
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Heart Rate	1 hour	63.6 Beats per minute	Standard Deviation 11.24
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Heart Rate	Pre dose	81.0 Beats per minute	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Heart Rate	15 minutes	74.0 Beats per minute	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Heart Rate	4 hours	75.0 Beats per minute	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Heart Rate	30 minutes	72.0 Beats per minute	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Heart Rate	1 hour	71.0 Beats per minute	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Heart Rate	5 minutes	74.0 Beats per minute	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Heart Rate	15 minutes	64.2 Beats per minute	Standard Deviation 16.3
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Heart Rate	4 hours	69.4 Beats per minute	Standard Deviation 15.11
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Heart Rate	Pre dose	63.6 Beats per minute	Standard Deviation 13.46
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Heart Rate	30 minutes	63.4 Beats per minute	Standard Deviation 13.22
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Heart Rate	5 minutes	76.6 Beats per minute	Standard Deviation 18.5
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Heart Rate	1 hour	63.8 Beats per minute	Standard Deviation 13.12

Primary

Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval

Triplicate 12-lead electrocardiograms (ECGs) were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measured PR interval, QRS duration, QTcB interval, and QTcF interval.

Time frame: Pre-dose, 2 minutes, 10 minutes, 20 minutes, 30 minutes, 1 hour and 4 hours post dose

Arm	Measure	Group	Value (MEAN)	Dispersion
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 2 minutes	144.6 Milliseconds	Standard Deviation 25.36
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 30 minutes	406.4 Milliseconds	Standard Deviation 13.96
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 1 hour	415.9 Milliseconds	Standard Deviation 15.66
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 20 minutes	416.0 Milliseconds	Standard Deviation 20.89
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 4 hours	410.4 Milliseconds	Standard Deviation 10.63
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 10 minutes	150.9 Milliseconds	Standard Deviation 27.9
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 10 minutes	421.3 Milliseconds	Standard Deviation 16.19
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 2 minutes	422.3 Milliseconds	Standard Deviation 30.97
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: Pre-dose	413.2 Milliseconds	Standard Deviation 20.41
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS: 4 hours	92.3 Milliseconds	Standard Deviation 9.52
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS: 1 hour	90.9 Milliseconds	Standard Deviation 8.15
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 1 hour	154.4 Milliseconds	Standard Deviation 28.92
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 30 minutes	91.3 Milliseconds	Standard Deviation 9.27
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 20 minutes	90.7 Milliseconds	Standard Deviation 8.96
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 10 minutes	92.3 Milliseconds	Standard Deviation 11.01
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 2 minutes	92.7 Milliseconds	Standard Deviation 7.11
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 2 minutes	403.0 Milliseconds	Standard Deviation 22.02
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: Pre-dose	150.9 Milliseconds	Standard Deviation 23.67
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: Pre-dose	91.4 Milliseconds	Standard Deviation 8.2
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 4 hours	153.1 Milliseconds	Standard Deviation 23.43
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 4 hours	422.4 Milliseconds	Standard Deviation 13.29
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 30 minutes	415.1 Milliseconds	Standard Deviation 22.11
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 30 minutes	151.4 Milliseconds	Standard Deviation 28.96
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 20 minutes	407.0 Milliseconds	Standard Deviation 14.87
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 10 minutes	407.0 Milliseconds	Standard Deviation 11.18
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 20 minutes	152.1 Milliseconds	Standard Deviation 29.59
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 1 hour	408.3 Milliseconds	Standard Deviation 11.9
400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: Pre-dose	401.7 Milliseconds	Standard Deviation 11.84
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 10 minutes	430.2 Milliseconds	Standard Deviation 20.23
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 1 hour	160.4 Milliseconds	Standard Deviation 22.88
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 2 minutes	89.4 Milliseconds	Standard Deviation 5.68
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 30 minutes	89.2 Milliseconds	Standard Deviation 5.22
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: Pre-dose	406.0 Milliseconds	Standard Deviation 19.51
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 2 minutes	422.6 Milliseconds	Standard Deviation 21.51
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 20 minutes	415.2 Milliseconds	Standard Deviation 26.22
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 1 hour	416.0 Milliseconds	Standard Deviation 20.76
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 4 hours	409.2 Milliseconds	Standard Deviation 17.63
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: Pre-dose	408.8 Milliseconds	Standard Deviation 24.01
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 2 minutes	453.4 Milliseconds	Standard Deviation 26.42
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 10 minutes	443.8 Milliseconds	Standard Deviation 22.71
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 30 minutes	420.2 Milliseconds	Standard Deviation 15.96
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: Pre-dose	156.0 Milliseconds	Standard Deviation 22.17
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 2 minutes	158.4 Milliseconds	Standard Deviation 24.13
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 10 minutes	161.6 Milliseconds	Standard Deviation 24.77
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 20 minutes	161.2 Milliseconds	Standard Deviation 26.4
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 30 minutes	158.8 Milliseconds	Standard Deviation 25.03
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 20 minutes	421.8 Milliseconds	Standard Deviation 29.04
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 30 minutes	427.8 Milliseconds	Standard Deviation 19.67
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 1 hour	419.5 Milliseconds	Standard Deviation 24.53
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 4 hours	415.5 Milliseconds	Standard Deviation 15.04
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 4 hours	155.8 Milliseconds	Standard Deviation 25.8
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: Pre-dose	89.0 Milliseconds	Standard Deviation 5.52
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 10 minutes	91.2 Milliseconds	Standard Deviation 5.67
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 20 minutes	87.8 Milliseconds	Standard Deviation 4.15
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS: 1 hour	89.6 Milliseconds	Standard Deviation 4.83
17 mcg Oxytocin IM	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS: 4 hours	88.6 Milliseconds	Standard Deviation 3.21
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 4 hours	439.0 Milliseconds	Standard Deviation 7.14
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 30 minutes	100.0 Milliseconds	Standard Deviation 0
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 20 minutes	143.5 Milliseconds	Standard Deviation 20.51
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 4 hours	420.5 Milliseconds	Standard Deviation 2.12
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 1 hour	435.4 Milliseconds	Standard Deviation 13.98
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 20 minutes	425.5 Milliseconds	Standard Deviation 2.54
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS: 4 hours	106.0 Milliseconds	Standard Deviation 8.49
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 2 minutes	146.5 Milliseconds	Standard Deviation 14.85
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 30 minutes	147.0 Milliseconds	Standard Deviation 14.14
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 10 minutes	98.5 Milliseconds	Standard Deviation 9.19
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 30 minutes	411.0 Milliseconds	Standard Deviation 19.8
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 2 minutes	464.4 Milliseconds	Standard Deviation 8.95
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 2 minutes	104.0 Milliseconds	Standard Deviation 4.24
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: Pre-dose	413.8 Milliseconds	Standard Deviation 26.37
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS: 1 hour	99.0 Milliseconds	Standard Deviation 1.41
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: Pre-dose	146.5 Milliseconds	Standard Deviation 21.92
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 20 minutes	419.5 Milliseconds	Standard Deviation 16.26
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: Pre-dose	99.0 Milliseconds	Standard Deviation 7.07
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 30 minutes	415.1 Milliseconds	Standard Deviation 7.05
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 1 hour	422.5 Milliseconds	Standard Deviation 0.71
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 10 minutes	429.0 Milliseconds	Standard Deviation 1.98
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: Pre-dose	406.5 Milliseconds	Standard Deviation 7.78
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 2 minutes	432.5 Milliseconds	Standard Deviation 20.51
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 4 hours	145.5 Milliseconds	Standard Deviation 16.26
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 10 minutes	143.0 Milliseconds	Standard Deviation 21.21
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 20 minutes	91.0 Milliseconds	Standard Deviation 18.38
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 10 minutes	413.5 Milliseconds	Standard Deviation 13.44
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 1 hour	147.5 Milliseconds	Standard Deviation 13.44
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 2 minutes	420.6 Milliseconds	Standard Deviation 12.5
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 20 minutes	422.0 Milliseconds	Standard Deviation 8.28
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 1 hour	420.2 Milliseconds	Standard Deviation 5.22
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 30 minutes	424.6 Milliseconds	Standard Deviation 8.2
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: Pre-dose	139.8 Milliseconds	Standard Deviation 23.67
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS: 1 hour	93.2 Milliseconds	Standard Deviation 9.34
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 2 minutes	140.0 Milliseconds	Standard Deviation 27.7
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 10 minutes	146.2 Milliseconds	Standard Deviation 28.65
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 20 minutes	147.4 Milliseconds	Standard Deviation 28.61
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 30 minutes	146.0 Milliseconds	Standard Deviation 24.37
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 20 minutes	432.9 Milliseconds	Standard Deviation 17.19
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS: 4 hours	89.0 Milliseconds	Standard Deviation 6.04
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 30 minutes	431.6 Milliseconds	Standard Deviation 18.64
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 1 hour	423.2 Milliseconds	Standard Deviation 15.57
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 10 minutes	422.6 Milliseconds	Standard Deviation 13.15
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 4 hours	421.9 Milliseconds	Standard Deviation 28.51
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 1 hour	146.8 Milliseconds	Standard Deviation 27.65
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 4 hours	141.6 Milliseconds	Standard Deviation 21.09
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: Pre-dose	91.4 Milliseconds	Standard Deviation 8.85
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 2 minutes	90.4 Milliseconds	Standard Deviation 9.32
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 10 minutes	91.2 Milliseconds	Standard Deviation 9.18
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: Pre-dose	413.8 Milliseconds	Standard Deviation 12.15
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 20 minutes	90.2 Milliseconds	Standard Deviation 9.55
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 30 minutes	93.4 Milliseconds	Standard Deviation 8.88
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: Pre-dose	420.4 Milliseconds	Standard Deviation 16.1
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 4 hours	408.2 Milliseconds	Standard Deviation 22.92
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 2 minutes	443.1 Milliseconds	Standard Deviation 20.62
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 10 minutes	434.1 Milliseconds	Standard Deviation 25.91
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 10 minutes	439.1 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 4 hours	429.3 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 1 hour	129.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 10 minutes	128.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS: 1 hour	91.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 4 hours	117.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 2 minutes	125.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: Pre-dose	127.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: Pre-dose	94.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 30 minutes	413.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 2 minutes	460.9 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 2 minutes	91.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: Pre-dose	416.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 2 minutes	426.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 10 minutes	91.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 1 hour	418.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 20 minutes	92.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 20 minutes	408.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 30 minutes	423.9 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 30 minutes	128.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 4 hours	410.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 20 minutes	418.4 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 10 minutes	421.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 30 minutes	93.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS: 4 hours	92.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 20 minutes	125.0 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: Pre-dose	441.7 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 1 hour	436.7 Milliseconds	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 30 minutes	419.6 Milliseconds	Standard Deviation 27.77
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 10 minutes	89.2 Milliseconds	Standard Deviation 9.58
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 4 hours	426.4 Milliseconds	Standard Deviation 17.82
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 10 minutes	146.0 Milliseconds	Standard Deviation 31.96
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 30 minutes	92.2 Milliseconds	Standard Deviation 10.62
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 30 minutes	417.0 Milliseconds	Standard Deviation 15.25
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 1 hour	150.0 Milliseconds	Standard Deviation 28.24
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 2 minutes	427.4 Milliseconds	Standard Deviation 19.3
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 20 minutes	89.0 Milliseconds	Standard Deviation 11.92
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 20 minutes	416.6 Milliseconds	Standard Deviation 16.29
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 1 hour	419.9 Milliseconds	Standard Deviation 25.24
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS: 1 hour	89.4 Milliseconds	Standard Deviation 8.88
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 4 hours	139.4 Milliseconds	Standard Deviation 29.37
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 20 minutes	418.9 Milliseconds	Standard Deviation 21.93
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: Pre-dose	139.6 Milliseconds	Standard Deviation 28.32
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: Pre-dose	418.4 Milliseconds	Standard Deviation 17.24
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 10 minutes	421.7 Milliseconds	Standard Deviation 18.96
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS: 4 hours	90.0 Milliseconds	Standard Deviation 6.6
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: Pre-dose	89.0 Milliseconds	Standard Deviation 9.85
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: Pre-dose	411.6 Milliseconds	Standard Deviation 9.63
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 4 hours	415.6 Milliseconds	Standard Deviation 12.54
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 1 hour	416.2 Milliseconds	Standard Deviation 18.57
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 30 minutes	151.8 Milliseconds	Standard Deviation 30.43
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QRS duration: 2 minutes	86.8 Milliseconds	Standard Deviation 6.26
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcF: 10 minutes	412.8 Milliseconds	Standard Deviation 8.96
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 20 minutes	151.0 Milliseconds	Standard Deviation 32.08
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	PR interval: 2 minutes	147.0 Milliseconds	Standard Deviation 30.36
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval	QTcB: 2 minutes	453.5 Milliseconds	Standard Deviation 30.42

Primary

Part 2: Absolute Values of Respiration Rate

Respiration rate was measured in semi-supine position after 5 minutes rest

Time frame: Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post-dose

Population: Safety Population. Only those participants with data available at specified data points were analyzed (represented by n=X in category titles). Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Arm	Measure	Group	Value (MEAN)	Dispersion
400 mcg Oxytocin IH	Part 2: Absolute Values of Respiration Rate	5 minutes, n=7,4,2,5,1,5	15.4 Breaths per minute	Standard Deviation 2.51
400 mcg Oxytocin IH	Part 2: Absolute Values of Respiration Rate	Pre dose, n=7,5,2,5,1,5	16.0 Breaths per minute	Standard Deviation 1.63
400 mcg Oxytocin IH	Part 2: Absolute Values of Respiration Rate	15 minutes, n=7,5,2,5,1,5	16.1 Breaths per minute	Standard Deviation 1.86
400 mcg Oxytocin IH	Part 2: Absolute Values of Respiration Rate	30 minutes, n=7,5,2,5,1,5	15.6 Breaths per minute	Standard Deviation 1.99
400 mcg Oxytocin IH	Part 2: Absolute Values of Respiration Rate	1 hour, n=7,5,2,5,1,5	15.4 Breaths per minute	Standard Deviation 0.79
400 mcg Oxytocin IH	Part 2: Absolute Values of Respiration Rate	4 hours, n=7,5,2,5,1,5	16.0 Breaths per minute	Standard Deviation 1.63
17 mcg Oxytocin IM	Part 2: Absolute Values of Respiration Rate	30 minutes, n=7,5,2,5,1,5	15.6 Breaths per minute	Standard Deviation 1.82
17 mcg Oxytocin IM	Part 2: Absolute Values of Respiration Rate	15 minutes, n=7,5,2,5,1,5	15.6 Breaths per minute	Standard Deviation 1.14
17 mcg Oxytocin IM	Part 2: Absolute Values of Respiration Rate	Pre dose, n=7,5,2,5,1,5	15.8 Breaths per minute	Standard Deviation 1.64
17 mcg Oxytocin IM	Part 2: Absolute Values of Respiration Rate	1 hour, n=7,5,2,5,1,5	15.6 Breaths per minute	Standard Deviation 1.14
17 mcg Oxytocin IM	Part 2: Absolute Values of Respiration Rate	5 minutes, n=7,4,2,5,1,5	17.0 Breaths per minute	Standard Deviation 2.16
17 mcg Oxytocin IM	Part 2: Absolute Values of Respiration Rate	4 hours, n=7,5,2,5,1,5	15.4 Breaths per minute	Standard Deviation 1.34
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Respiration Rate	1 hour, n=7,5,2,5,1,5	15.0 Breaths per minute	Standard Deviation 1.41
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Respiration Rate	30 minutes, n=7,5,2,5,1,5	14.5 Breaths per minute	Standard Deviation 0.71
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Respiration Rate	4 hours, n=7,5,2,5,1,5	17.5 Breaths per minute	Standard Deviation 0.71
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Respiration Rate	15 minutes, n=7,5,2,5,1,5	15.5 Breaths per minute	Standard Deviation 0.71
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Respiration Rate	5 minutes, n=7,4,2,5,1,5	17.0 Breaths per minute	Standard Deviation 2.83
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Respiration Rate	Pre dose, n=7,5,2,5,1,5	18.0 Breaths per minute	Standard Deviation 1.41
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Respiration Rate	Pre dose, n=7,5,2,5,1,5	14.8 Breaths per minute	Standard Deviation 1.79
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Respiration Rate	5 minutes, n=7,4,2,5,1,5	15.2 Breaths per minute	Standard Deviation 1.3
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Respiration Rate	15 minutes, n=7,5,2,5,1,5	15.4 Breaths per minute	Standard Deviation 0.55
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Respiration Rate	4 hours, n=7,5,2,5,1,5	15.0 Breaths per minute	Standard Deviation 2
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Respiration Rate	30 minutes, n=7,5,2,5,1,5	15.0 Breaths per minute	Standard Deviation 1.87
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Respiration Rate	1 hour, n=7,5,2,5,1,5	13.8 Breaths per minute	Standard Deviation 2.05
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Respiration Rate	Pre dose, n=7,5,2,5,1,5	18.0 Breaths per minute	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Respiration Rate	15 minutes, n=7,5,2,5,1,5	14.0 Breaths per minute	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Respiration Rate	1 hour, n=7,5,2,5,1,5	14.0 Breaths per minute	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Respiration Rate	5 minutes, n=7,4,2,5,1,5	14.0 Breaths per minute	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Respiration Rate	30 minutes, n=7,5,2,5,1,5	14.0 Breaths per minute	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Respiration Rate	4 hours, n=7,5,2,5,1,5	15.0 Breaths per minute	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Respiration Rate	30 minutes, n=7,5,2,5,1,5	15.6 Breaths per minute	Standard Deviation 1.14
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Respiration Rate	15 minutes, n=7,5,2,5,1,5	16.6 Breaths per minute	Standard Deviation 2.7
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Respiration Rate	1 hour, n=7,5,2,5,1,5	15.6 Breaths per minute	Standard Deviation 0.89
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Respiration Rate	4 hours, n=7,5,2,5,1,5	15.6 Breaths per minute	Standard Deviation 1.52
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Respiration Rate	5 minutes, n=7,4,2,5,1,5	16.8 Breaths per minute	Standard Deviation 2.28
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Respiration Rate	Pre dose, n=7,5,2,5,1,5	15.0 Breaths per minute	Standard Deviation 2

Primary

Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.

Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose

Arm	Measure	Group	Value (MEAN)	Dispersion
400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 1 hour	65.9 Millimeters of mercury	Standard Deviation 4.85
400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: Pre-dose	107.1 Millimeters of mercury	Standard Deviation 5.24
400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 4 hours	66.4 Millimeters of mercury	Standard Deviation 7.57
400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: Pre-dose	65.1 Millimeters of mercury	Standard Deviation 5.93
400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 4 hours	106.9 Millimeters of mercury	Standard Deviation 5.11
400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 1 hour	104.9 Millimeters of mercury	Standard Deviation 6.26
400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 30 minutes	68.3 Millimeters of mercury	Standard Deviation 6.07
400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 15 minutes	65.4 Millimeters of mercury	Standard Deviation 5.62
400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 5 minutes	67.1 Millimeters of mercury	Standard Deviation 7.67
400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 15 minutes	108.9 Millimeters of mercury	Standard Deviation 3.29
400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 5 minutes	114.0 Millimeters of mercury	Standard Deviation 6.16
400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 30 minutes	109.6 Millimeters of mercury	Standard Deviation 4.04
17 mcg Oxytocin IM	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 4 hours	61.6 Millimeters of mercury	Standard Deviation 6.99
17 mcg Oxytocin IM	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 5 minutes	67.0 Millimeters of mercury	Standard Deviation 8.15
17 mcg Oxytocin IM	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 15 minutes	64.8 Millimeters of mercury	Standard Deviation 7.43
17 mcg Oxytocin IM	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 30 minutes	111.2 Millimeters of mercury	Standard Deviation 6.87
17 mcg Oxytocin IM	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 1 hour	65.8 Millimeters of mercury	Standard Deviation 3.56
17 mcg Oxytocin IM	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: Pre-dose	116.0 Millimeters of mercury	Standard Deviation 12.73
17 mcg Oxytocin IM	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 5 minutes	118.2 Millimeters of mercury	Standard Deviation 9.76
17 mcg Oxytocin IM	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 15 minutes	114.6 Millimeters of mercury	Standard Deviation 9.4
17 mcg Oxytocin IM	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 1 hour	111.4 Millimeters of mercury	Standard Deviation 5.37
17 mcg Oxytocin IM	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 4 hours	111.4 Millimeters of mercury	Standard Deviation 11.28
17 mcg Oxytocin IM	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 30 minutes	65.2 Millimeters of mercury	Standard Deviation 3.11
17 mcg Oxytocin IM	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: Pre-dose	62.4 Millimeters of mercury	Standard Deviation 7.54
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 4 hours	64.5 Millimeters of mercury	Standard Deviation 9.19
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 5 minutes	61.5 Millimeters of mercury	Standard Deviation 7.78
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 5 minutes	103.5 Millimeters of mercury	Standard Deviation 9.19
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 4 hours	106.5 Millimeters of mercury	Standard Deviation 3.54
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 15 minutes	106.0 Millimeters of mercury	Standard Deviation 5.66
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 30 minutes	107.0 Millimeters of mercury	Standard Deviation 8.49
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: Pre-dose	67.0 Millimeters of mercury	Standard Deviation 1.41
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 1 hour	69.0 Millimeters of mercury	Standard Deviation 5.66
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 1 hour	103.5 Millimeters of mercury	Standard Deviation 2.12
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 30 minutes	66.5 Millimeters of mercury	Standard Deviation 4.95
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 15 minutes	65.5 Millimeters of mercury	Standard Deviation 4.95
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: Pre-dose	102.0 Millimeters of mercury	Standard Deviation 5.66
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: Pre-dose	105.4 Millimeters of mercury	Standard Deviation 10.11
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: Pre-dose	62.0 Millimeters of mercury	Standard Deviation 6.36
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 4 hours	60.0 Millimeters of mercury	Standard Deviation 6.52
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 30 minutes	113.2 Millimeters of mercury	Standard Deviation 12.05
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 5 minutes	65.2 Millimeters of mercury	Standard Deviation 3.03
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 5 minutes	108.4 Millimeters of mercury	Standard Deviation 10.71
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 4 hours	102.0 Millimeters of mercury	Standard Deviation 9.41
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 15 minutes	65.6 Millimeters of mercury	Standard Deviation 3.36
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 1 hour	66.6 Millimeters of mercury	Standard Deviation 2.41
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 15 minutes	106.4 Millimeters of mercury	Standard Deviation 9.5
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 1 hour	108.8 Millimeters of mercury	Standard Deviation 8.64
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 30 minutes	69.6 Millimeters of mercury	Standard Deviation 6.73
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 5 minutes	67.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 4 hours	93.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: Pre-dose	58.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 1 hour	65.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: Pre-dose	99.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 15 minutes	98.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 30 minutes	100.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 1 hour	98.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 5 minutes	104.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 15 minutes	68.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 30 minutes	70.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 4 hours	62.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 4 hours	106.4 Millimeters of mercury	Standard Deviation 3.21
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 1 hour	109.0 Millimeters of mercury	Standard Deviation 12.61
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 15 minutes	106.0 Millimeters of mercury	Standard Deviation 10.07
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 4 hours	59.2 Millimeters of mercury	Standard Deviation 5.07
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 30 minutes	63.0 Millimeters of mercury	Standard Deviation 5.48
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: Pre-dose	107.2 Millimeters of mercury	Standard Deviation 6.61
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 1 hour	66.4 Millimeters of mercury	Standard Deviation 9.21
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: Pre-dose	64.2 Millimeters of mercury	Standard Deviation 8.29
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 30 minutes	104.6 Millimeters of mercury	Standard Deviation 10.95
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 5 minutes	110.6 Millimeters of mercury	Standard Deviation 15.14
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 15 minutes	62.4 Millimeters of mercury	Standard Deviation 5.77
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 5 minutes	60.4 Millimeters of mercury	Standard Deviation 5.68

Primary

Part 2: Area Under the Concentration-time Curve From Time Zero Extrapolated to Time 't' (AUC[0-t]) of Oxytocin

Blood samples were collected at indicated time points to evaluate AUC (0-t) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Time frame: -1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Participants analysed (23) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
400 mcg Oxytocin IH	Part 2: Area Under the Concentration-time Curve From Time Zero Extrapolated to Time 't' (AUC[0-t]) of Oxytocin	127.58 Hour*picogram per milliliter	Geometric Coefficient of Variation 58.6
17 mcg Oxytocin IM	Part 2: Area Under the Concentration-time Curve From Time Zero Extrapolated to Time 't' (AUC[0-t]) of Oxytocin	161.39 Hour*picogram per milliliter	Geometric Coefficient of Variation 44.1
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Area Under the Concentration-time Curve From Time Zero Extrapolated to Time 't' (AUC[0-t]) of Oxytocin	164.46 Hour*picogram per milliliter	Geometric Coefficient of Variation 15.8
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Area Under the Concentration-time Curve From Time Zero Extrapolated to Time 't' (AUC[0-t]) of Oxytocin	247.42 Hour*picogram per milliliter	Geometric Coefficient of Variation 22.3
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Area Under the Concentration-time Curve From Time Zero Extrapolated to Time 't' (AUC[0-t]) of Oxytocin	208.37 Hour*picogram per milliliter	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Area Under the Concentration-time Curve From Time Zero Extrapolated to Time 't' (AUC[0-t]) of Oxytocin	171.21 Hour*picogram per milliliter	Geometric Coefficient of Variation 23.9

Primary

Part 2: Change From Baseline in Heart Rate

Heart rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Time frame: Baseline (Day 1, pre-dose), 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose

Arm	Measure	Group	Value (MEAN)	Dispersion
400 mcg Oxytocin IH	Part 2: Change From Baseline in Heart Rate	5 minutes	2.9 Beats per minute	Standard Deviation 6.99
400 mcg Oxytocin IH	Part 2: Change From Baseline in Heart Rate	4 hours	3.1 Beats per minute	Standard Deviation 6.49
400 mcg Oxytocin IH	Part 2: Change From Baseline in Heart Rate	15 minutes	2.9 Beats per minute	Standard Deviation 11.51
400 mcg Oxytocin IH	Part 2: Change From Baseline in Heart Rate	1 hour	-5.9 Beats per minute	Standard Deviation 7.15
400 mcg Oxytocin IH	Part 2: Change From Baseline in Heart Rate	30 minutes	-1.9 Beats per minute	Standard Deviation 7.29
17 mcg Oxytocin IM	Part 2: Change From Baseline in Heart Rate	30 minutes	1.2 Beats per minute	Standard Deviation 11.34
17 mcg Oxytocin IM	Part 2: Change From Baseline in Heart Rate	5 minutes	13.8 Beats per minute	Standard Deviation 11.86
17 mcg Oxytocin IM	Part 2: Change From Baseline in Heart Rate	4 hours	5.8 Beats per minute	Standard Deviation 11.5
17 mcg Oxytocin IM	Part 2: Change From Baseline in Heart Rate	15 minutes	4.4 Beats per minute	Standard Deviation 9.4
17 mcg Oxytocin IM	Part 2: Change From Baseline in Heart Rate	1 hour	2.2 Beats per minute	Standard Deviation 8.56
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in Heart Rate	30 minutes	1 Beats per minute	Standard Deviation 1.41
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in Heart Rate	15 minutes	7 Beats per minute	Standard Deviation 7.07
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in Heart Rate	5 minutes	19.5 Beats per minute	Standard Deviation 3.54
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in Heart Rate	4 hours	9 Beats per minute	Standard Deviation 22.63
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in Heart Rate	1 hour	4.5 Beats per minute	Standard Deviation 6.36
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Change From Baseline in Heart Rate	15 minutes	2.6 Beats per minute	Standard Deviation 12.44
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Change From Baseline in Heart Rate	4 hours	6.2 Beats per minute	Standard Deviation 5.4
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Change From Baseline in Heart Rate	5 minutes	7.4 Beats per minute	Standard Deviation 13.05
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Change From Baseline in Heart Rate	30 minutes	-3.6 Beats per minute	Standard Deviation 11.74
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Change From Baseline in Heart Rate	1 hour	-1.4 Beats per minute	Standard Deviation 10.04
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Change From Baseline in Heart Rate	30 minutes	-9.0 Beats per minute	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Change From Baseline in Heart Rate	15 minutes	-7.0 Beats per minute	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Change From Baseline in Heart Rate	5 minutes	-7.0 Beats per minute	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Change From Baseline in Heart Rate	1 hour	-10.0 Beats per minute	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Change From Baseline in Heart Rate	4 hours	-6.0 Beats per minute	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in Heart Rate	4 hours	5.8 Beats per minute	Standard Deviation 3.49
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in Heart Rate	5 minutes	13.0 Beats per minute	Standard Deviation 7.52
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in Heart Rate	30 minutes	-0.2 Beats per minute	Standard Deviation 4.09
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in Heart Rate	1 hour	0.2 Beats per minute	Standard Deviation 3.96
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in Heart Rate	15 minutes	0.6 Beats per minute	Standard Deviation 3.29

Primary

Part 2: Change From Baseline in SBP and DBP

SBP and DBP of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Time frame: Baseline (Day 1, pre-dose), 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose

Arm	Measure	Group	Value (MEAN)	Dispersion
400 mcg Oxytocin IH	Part 2: Change From Baseline in SBP and DBP	DBP: 5 minutes	2.0 Millimeters of mercury	Standard Deviation 10.69
400 mcg Oxytocin IH	Part 2: Change From Baseline in SBP and DBP	DBP: 4 hours	1.3 Millimeters of mercury	Standard Deviation 8.2
400 mcg Oxytocin IH	Part 2: Change From Baseline in SBP and DBP	DBP: 1 hour	0.7 Millimeters of mercury	Standard Deviation 3.35
400 mcg Oxytocin IH	Part 2: Change From Baseline in SBP and DBP	SBP: 1 hour	-2.3 Millimeters of mercury	Standard Deviation 4.27
400 mcg Oxytocin IH	Part 2: Change From Baseline in SBP and DBP	DBP: 30 minutes	3.1 Millimeters of mercury	Standard Deviation 7.88
400 mcg Oxytocin IH	Part 2: Change From Baseline in SBP and DBP	DBP: 15 minutes	0.3 Millimeters of mercury	Standard Deviation 6.92
400 mcg Oxytocin IH	Part 2: Change From Baseline in SBP and DBP	SBP: 5 minutes	6.9 Millimeters of mercury	Standard Deviation 6.47
400 mcg Oxytocin IH	Part 2: Change From Baseline in SBP and DBP	SBP: 4 hours	-0.3 Millimeters of mercury	Standard Deviation 3.82
400 mcg Oxytocin IH	Part 2: Change From Baseline in SBP and DBP	SBP: 30 minutes	2.4 Millimeters of mercury	Standard Deviation 2.07
400 mcg Oxytocin IH	Part 2: Change From Baseline in SBP and DBP	SBP: 15 minutes	1.7 Millimeters of mercury	Standard Deviation 3.25
17 mcg Oxytocin IM	Part 2: Change From Baseline in SBP and DBP	SBP: 4 hours	-4.6 Millimeters of mercury	Standard Deviation 13.79
17 mcg Oxytocin IM	Part 2: Change From Baseline in SBP and DBP	SBP: 5 minutes	2.2 Millimeters of mercury	Standard Deviation 13.42
17 mcg Oxytocin IM	Part 2: Change From Baseline in SBP and DBP	SBP: 1 hour	-4.6 Millimeters of mercury	Standard Deviation 14.1
17 mcg Oxytocin IM	Part 2: Change From Baseline in SBP and DBP	DBP: 4 hours	-0.8 Millimeters of mercury	Standard Deviation 4.97
17 mcg Oxytocin IM	Part 2: Change From Baseline in SBP and DBP	SBP: 15 minutes	-1.4 Millimeters of mercury	Standard Deviation 14.67
17 mcg Oxytocin IM	Part 2: Change From Baseline in SBP and DBP	SBP: 30 minutes	-4.8 Millimeters of mercury	Standard Deviation 13.35
17 mcg Oxytocin IM	Part 2: Change From Baseline in SBP and DBP	DBP: 5 minutes	4.6 Millimeters of mercury	Standard Deviation 3.58
17 mcg Oxytocin IM	Part 2: Change From Baseline in SBP and DBP	DBP: 15 minutes	2.4 Millimeters of mercury	Standard Deviation 7.7
17 mcg Oxytocin IM	Part 2: Change From Baseline in SBP and DBP	DBP: 30 minutes	2.8 Millimeters of mercury	Standard Deviation 8.04
17 mcg Oxytocin IM	Part 2: Change From Baseline in SBP and DBP	DBP: 1 hour	3.4 Millimeters of mercury	Standard Deviation 6.54
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in SBP and DBP	DBP: 5 minutes	-5.5 Millimeters of mercury	Standard Deviation 9.19
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in SBP and DBP	DBP: 1 hour	2.0 Millimeters of mercury	Standard Deviation 7.07
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in SBP and DBP	SBP: 15 minutes	4.0 Millimeters of mercury	Standard Deviation 0
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in SBP and DBP	SBP: 5 minutes	1.5 Millimeters of mercury	Standard Deviation 3.54
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in SBP and DBP	SBP: 4 hours	4.5 Millimeters of mercury	Standard Deviation 2.12
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in SBP and DBP	SBP: 30 minutes	5.0 Millimeters of mercury	Standard Deviation 2.83
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in SBP and DBP	DBP: 4 hours	-2.5 Millimeters of mercury	Standard Deviation 10.61
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in SBP and DBP	DBP: 30 minutes	-0.5 Millimeters of mercury	Standard Deviation 6.36
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in SBP and DBP	DBP: 15 minutes	-1.5 Millimeters of mercury	Standard Deviation 6.36
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in SBP and DBP	SBP: 1 hour	1.5 Millimeters of mercury	Standard Deviation 3.54
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Change From Baseline in SBP and DBP	DBP: 5 minutes	3.2 Millimeters of mercury	Standard Deviation 6.46
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Change From Baseline in SBP and DBP	DBP: 4 hours	-2.0 Millimeters of mercury	Standard Deviation 3.24
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Change From Baseline in SBP and DBP	SBP: 1 hour	3.4 Millimeters of mercury	Standard Deviation 13.54
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Change From Baseline in SBP and DBP	SBP: 5 minutes	3.0 Millimeters of mercury	Standard Deviation 10.42
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Change From Baseline in SBP and DBP	DBP: 30 minutes	7.6 Millimeters of mercury	Standard Deviation 9.94
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Change From Baseline in SBP and DBP	SBP: 15 minutes	1.0 Millimeters of mercury	Standard Deviation 11.02
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Change From Baseline in SBP and DBP	SBP: 30 minutes	7.8 Millimeters of mercury	Standard Deviation 12.56
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Change From Baseline in SBP and DBP	SBP: 4 hours	-3.4 Millimeters of mercury	Standard Deviation 9.29
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Change From Baseline in SBP and DBP	DBP: 1 hour	4.6 Millimeters of mercury	Standard Deviation 3.97
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Change From Baseline in SBP and DBP	DBP: 15 minutes	3.6 Millimeters of mercury	Standard Deviation 4.28
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Change From Baseline in SBP and DBP	SBP: 30 minutes	1.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Change From Baseline in SBP and DBP	SBP: 1 hour	-1.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Change From Baseline in SBP and DBP	SBP: 15 minutes	-1.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Change From Baseline in SBP and DBP	DBP: 5 minutes	9.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Change From Baseline in SBP and DBP	SBP: 5 minutes	5.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Change From Baseline in SBP and DBP	DBP: 1 hour	7.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Change From Baseline in SBP and DBP	DBP: 4 hours	4.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Change From Baseline in SBP and DBP	DBP: 15 minutes	10.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Change From Baseline in SBP and DBP	SBP: 4 hours	-6.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Change From Baseline in SBP and DBP	DBP: 30 minutes	12.0 Millimeters of mercury	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in SBP and DBP	SBP: 15 minutes	-1.2 Millimeters of mercury	Standard Deviation 6.98
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in SBP and DBP	SBP: 30 minutes	-2.6 Millimeters of mercury	Standard Deviation 7.8
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in SBP and DBP	DBP: 4 hours	-5.0 Millimeters of mercury	Standard Deviation 6.63
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in SBP and DBP	SBP: 1 hour	1.8 Millimeters of mercury	Standard Deviation 9.71
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in SBP and DBP	DBP: 30 minutes	-1.2 Millimeters of mercury	Standard Deviation 4.87
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in SBP and DBP	DBP: 15 minutes	-1.8 Millimeters of mercury	Standard Deviation 5.5
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in SBP and DBP	DBP: 1 hour	2.2 Millimeters of mercury	Standard Deviation 2.95
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in SBP and DBP	SBP: 4 hours	-0.8 Millimeters of mercury	Standard Deviation 7.95
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in SBP and DBP	SBP: 5 minutes	3.4 Millimeters of mercury	Standard Deviation 10.88
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Change From Baseline in SBP and DBP	DBP: 5 minutes	-3.8 Millimeters of mercury	Standard Deviation 3.35

Primary

Part 2: Forced Expiratory Volume at 1 Minute (FEV1)

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements were taken electronically by spirometry on Day 1. At each time point, three best measurements were recorded.

Time frame: Pre dose and 1 hour post dose on Day1

Arm	Measure	Group	Value (MEAN)	Dispersion
400 mcg Oxytocin IH	Part 2: Forced Expiratory Volume at 1 Minute (FEV1)	Pre-dose	3.251 Liters	Standard Deviation 0.3125
400 mcg Oxytocin IH	Part 2: Forced Expiratory Volume at 1 Minute (FEV1)	1 hour	3.184 Liters	Standard Deviation 0.2769
17 mcg Oxytocin IM	Part 2: Forced Expiratory Volume at 1 Minute (FEV1)	Pre-dose	3.440 Liters	Standard Deviation 0.3121
17 mcg Oxytocin IM	Part 2: Forced Expiratory Volume at 1 Minute (FEV1)	1 hour	3.374 Liters	Standard Deviation 0.2964
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Forced Expiratory Volume at 1 Minute (FEV1)	Pre-dose	3.130 Liters	Standard Deviation 0.0707
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Forced Expiratory Volume at 1 Minute (FEV1)	1 hour	3.110 Liters	Standard Deviation 0.198
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Forced Expiratory Volume at 1 Minute (FEV1)	Pre-dose	3.384 Liters	Standard Deviation 0.3051
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Forced Expiratory Volume at 1 Minute (FEV1)	1 hour	3.306 Liters	Standard Deviation 0.2874
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Forced Expiratory Volume at 1 Minute (FEV1)	Pre-dose	3.630 Liters	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Forced Expiratory Volume at 1 Minute (FEV1)	1 hour	3.380 Liters	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Forced Expiratory Volume at 1 Minute (FEV1)	Pre-dose	3.284 Liters	Standard Deviation 0.3488
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Forced Expiratory Volume at 1 Minute (FEV1)	1 hour	3.190 Liters	Standard Deviation 0.3768

Primary

Part 2: Maximum Observed Plasma Concentration (Cmax) of Oxytocin

Blood samples were collected at indicated time points to evaluate Cmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Time frame: -1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
400 mcg Oxytocin IH	Part 2: Maximum Observed Plasma Concentration (Cmax) of Oxytocin	224.25 Picogram per milliliter	Geometric Coefficient of Variation 92.5
17 mcg Oxytocin IM	Part 2: Maximum Observed Plasma Concentration (Cmax) of Oxytocin	838.25 Picogram per milliliter	Geometric Coefficient of Variation 67.2
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Maximum Observed Plasma Concentration (Cmax) of Oxytocin	697.74 Picogram per milliliter	Geometric Coefficient of Variation 0
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Maximum Observed Plasma Concentration (Cmax) of Oxytocin	357.38 Picogram per milliliter	Geometric Coefficient of Variation 51.4
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Maximum Observed Plasma Concentration (Cmax) of Oxytocin	1312.74 Picogram per milliliter	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Maximum Observed Plasma Concentration (Cmax) of Oxytocin	721.68 Picogram per milliliter	Geometric Coefficient of Variation 42.2

Primary

Part 2: Number of Participants With Abnormal Respiratory Events

Number of participants with abnormal respiratory events has been presented

Time frame: Up to Day 37

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
400 mcg Oxytocin IH	Part 2: Number of Participants With Abnormal Respiratory Events	2 Participants
17 mcg Oxytocin IM	Part 2: Number of Participants With Abnormal Respiratory Events	1 Participants
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Number of Participants With Abnormal Respiratory Events	0 Participants
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Number of Participants With Abnormal Respiratory Events	0 Participants
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Number of Participants With Abnormal Respiratory Events	0 Participants
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Number of Participants With Abnormal Respiratory Events	0 Participants

Primary

Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)

An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. As SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety Population includes participants who received at least one dose of study medication.

Time frame: Up to 37 days

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
400 mcg Oxytocin IH	Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)	Any non-SAE	7 Participants
400 mcg Oxytocin IH	Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)	Any SAE	0 Participants
17 mcg Oxytocin IM	Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)	Any non-SAE	5 Participants
17 mcg Oxytocin IM	Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)	Any SAE	0 Participants
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)	Any non-SAE	1 Participants
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)	Any SAE	0 Participants
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)	Any non-SAE	3 Participants
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)	Any SAE	0 Participants
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)	Any non-SAE	1 Participants
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)	Any SAE	0 Participants
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)	Any SAE	0 Participants
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)	Any non-SAE	5 Participants

Primary

Part 2: Observed Plasma Concentration (Cp)10 of Oxytocin

Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Time frame: 10 minutes post dose

Population: Pharmacokinetic Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
400 mcg Oxytocin IH	Part 2: Observed Plasma Concentration (Cp)10 of Oxytocin	179.98 Picogram per milliliter	Geometric Coefficient of Variation 79.6
17 mcg Oxytocin IM	Part 2: Observed Plasma Concentration (Cp)10 of Oxytocin	293.00 Picogram per milliliter	Geometric Coefficient of Variation 32.1
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Observed Plasma Concentration (Cp)10 of Oxytocin	421.87 Picogram per milliliter	Geometric Coefficient of Variation 9.1
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Observed Plasma Concentration (Cp)10 of Oxytocin	292.95 Picogram per milliliter	Geometric Coefficient of Variation 37.7
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Observed Plasma Concentration (Cp)10 of Oxytocin	431.98 Picogram per milliliter	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Observed Plasma Concentration (Cp)10 of Oxytocin	407.99 Picogram per milliliter	Geometric Coefficient of Variation 39.6

Primary

Part 2: Observed Plasma Concentration (Cp)20 of Oxytocin

Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Time frame: 20 minutes post dose

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
400 mcg Oxytocin IH	Part 2: Observed Plasma Concentration (Cp)20 of Oxytocin	131.72 Picogram per milliliter	Geometric Coefficient of Variation 61.1
17 mcg Oxytocin IM	Part 2: Observed Plasma Concentration (Cp)20 of Oxytocin	110.44 Picogram per milliliter	Geometric Coefficient of Variation 26
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Observed Plasma Concentration (Cp)20 of Oxytocin	141.75 Picogram per milliliter	Geometric Coefficient of Variation 38.5
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Observed Plasma Concentration (Cp)20 of Oxytocin	231.76 Picogram per milliliter	Geometric Coefficient of Variation 22.2
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Observed Plasma Concentration (Cp)20 of Oxytocin	159.50 Picogram per milliliter	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Observed Plasma Concentration (Cp)20 of Oxytocin	131.21 Picogram per milliliter	Geometric Coefficient of Variation 25.8

Primary

Part 2: Observed Plasma Concentration (Cp)30 of Oxytocin

Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Time frame: 30 minutes post dose

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
400 mcg Oxytocin IH	Part 2: Observed Plasma Concentration (Cp)30 of Oxytocin	93.54 Picogram per milliliter	Geometric Coefficient of Variation 49.6
17 mcg Oxytocin IM	Part 2: Observed Plasma Concentration (Cp)30 of Oxytocin	56.70 Picogram per milliliter	Geometric Coefficient of Variation 26.3
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Observed Plasma Concentration (Cp)30 of Oxytocin	72.17 Picogram per milliliter	Geometric Coefficient of Variation 45.8
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Observed Plasma Concentration (Cp)30 of Oxytocin	184.71 Picogram per milliliter	Geometric Coefficient of Variation 20.6
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Observed Plasma Concentration (Cp)30 of Oxytocin	80.12 Picogram per milliliter	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Observed Plasma Concentration (Cp)30 of Oxytocin	63.02 Picogram per milliliter	Geometric Coefficient of Variation 20.6

Primary

Part 2: Percent Oxygen in Blood

Percent oxygen in blood was measured using pulse oximetry in a semi-supine position after 5 minutes rest. Pulse oximeter is a device that measures oxygen saturation of arterial blood in participants by utilizing a sensor attached typically to a finger, toe, or ear to determine the percentage of oxyhemoglobin in blood pulsating through a network of capillaries

Time frame: Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post-dose

Arm	Measure	Group	Value (MEAN)	Dispersion
400 mcg Oxytocin IH	Part 2: Percent Oxygen in Blood	Pre dose	98.6 Percentage of oxygen	Standard Deviation 1.4
400 mcg Oxytocin IH	Part 2: Percent Oxygen in Blood	15 minutes	98.7 Percentage of oxygen	Standard Deviation 1.25
400 mcg Oxytocin IH	Part 2: Percent Oxygen in Blood	1 hour	98.4 Percentage of oxygen	Standard Deviation 1.27
400 mcg Oxytocin IH	Part 2: Percent Oxygen in Blood	30 minutes	98.9 Percentage of oxygen	Standard Deviation 0.9
400 mcg Oxytocin IH	Part 2: Percent Oxygen in Blood	5 minutes	98.9 Percentage of oxygen	Standard Deviation 1.21
400 mcg Oxytocin IH	Part 2: Percent Oxygen in Blood	4 hours	99.0 Percentage of oxygen	Standard Deviation 0.82
17 mcg Oxytocin IM	Part 2: Percent Oxygen in Blood	30 minutes	98.4 Percentage of oxygen	Standard Deviation 1.14
17 mcg Oxytocin IM	Part 2: Percent Oxygen in Blood	4 hours	98.4 Percentage of oxygen	Standard Deviation 0.89
17 mcg Oxytocin IM	Part 2: Percent Oxygen in Blood	15 minutes	98.8 Percentage of oxygen	Standard Deviation 0.84
17 mcg Oxytocin IM	Part 2: Percent Oxygen in Blood	1 hour	98.2 Percentage of oxygen	Standard Deviation 1.3
17 mcg Oxytocin IM	Part 2: Percent Oxygen in Blood	Pre dose	99.4 Percentage of oxygen	Standard Deviation 0.89
17 mcg Oxytocin IM	Part 2: Percent Oxygen in Blood	5 minutes	99.0 Percentage of oxygen	Standard Deviation 1
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Percent Oxygen in Blood	15 minutes	99.5 Percentage of oxygen	Standard Deviation 0.71
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Percent Oxygen in Blood	4 hours	99.5 Percentage of oxygen	Standard Deviation 0.71
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Percent Oxygen in Blood	5 minutes	99.0 Percentage of oxygen	Standard Deviation 1.41
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Percent Oxygen in Blood	30 minutes	99.5 Percentage of oxygen	Standard Deviation 0.71
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Percent Oxygen in Blood	Pre dose	99.0 Percentage of oxygen	Standard Deviation 1.41
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Percent Oxygen in Blood	1 hour	99.0 Percentage of oxygen	Standard Deviation 1.41
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Percent Oxygen in Blood	5 minutes	98.0 Percentage of oxygen	Standard Deviation 1.41
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Percent Oxygen in Blood	Pre dose	97.2 Percentage of oxygen	Standard Deviation 0.84
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Percent Oxygen in Blood	30 minutes	98.2 Percentage of oxygen	Standard Deviation 0.84
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Percent Oxygen in Blood	1 hour	98 Percentage of oxygen	Standard Deviation 0.71
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Percent Oxygen in Blood	4 hours	97.8 Percentage of oxygen	Standard Deviation 0.84
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Percent Oxygen in Blood	15 minutes	97.8 Percentage of oxygen	Standard Deviation 1.1
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Percent Oxygen in Blood	5 minutes	98.0 Percentage of oxygen	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Percent Oxygen in Blood	1 hour	99.0 Percentage of oxygen	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Percent Oxygen in Blood	Pre dose	98.0 Percentage of oxygen	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Percent Oxygen in Blood	4 hours	99.0 Percentage of oxygen	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Percent Oxygen in Blood	15 minutes	98.0 Percentage of oxygen	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Percent Oxygen in Blood	30 minutes	98.0 Percentage of oxygen	—
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Percent Oxygen in Blood	4 hours	98.6 Percentage of oxygen	Standard Deviation 1.52
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Percent Oxygen in Blood	Pre dose	97.4 Percentage of oxygen	Standard Deviation 0.89
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Percent Oxygen in Blood	5 minutes	98.8 Percentage of oxygen	Standard Deviation 1.3
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Percent Oxygen in Blood	15 minutes	98.4 Percentage of oxygen	Standard Deviation 1.14
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Percent Oxygen in Blood	30 minutes	98.2 Percentage of oxygen	Standard Deviation 1.1
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Percent Oxygen in Blood	1 hour	98.2 Percentage of oxygen	Standard Deviation 1.1

Primary

Part 2: Plasma Clearance (CL) of Oxytocin for IV Route Only

Blood samples were collected at indicated time points to evaluate plasma clearance of oxytocin IV bolus and infusion. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Only IV reporting arms presented.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
400 mcg Oxytocin IH	Part 2: Plasma Clearance (CL) of Oxytocin for IV Route Only	57.93 Liters per hour	Geometric Coefficient of Variation 46.3
17 mcg Oxytocin IM	Part 2: Plasma Clearance (CL) of Oxytocin for IV Route Only	50.85 Liters per hour	Geometric Coefficient of Variation 16.1
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Clearance (CL) of Oxytocin for IV Route Only	40.44 Liters per hour	—
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Plasma Clearance (CL) of Oxytocin for IV Route Only	49.23 Liters per hour	Geometric Coefficient of Variation 23.6

Primary

Part 2: Plasma Concentration Time Profile of Oxytocin.

Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Population: Pharmacokinetic Population. Only those participants with data available at specified data points were analyzed (represented by n=X in category titles). Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Arm	Measure	Group	Value (MEDIAN)
400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	45 minutes; n=7, 4, 2, 5, 1, 4	54.400 Picograms per milliliter
400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	2 minutes; n=7, 3, 2, 5, 1, 4	114.840 Picograms per milliliter
400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	3 Hours; n=7, 4, 2, 5, 1, 4	2.470 Picograms per milliliter
400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	-15 minutes; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	2.5 Hours; n=7, 4, 2, 5, 1, 4	4.090 Picograms per milliliter
400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	1.5 Hours; n=7, 4, 2, 5, 1, 4	16.180 Picograms per milliliter
400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	4 Hours; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	3 minutes; n=7, 3, 2, 5, 1, 4	157.710 Picograms per milliliter
400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	-30 minutes; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	2 Hours; n=7, 4, 2, 5, 1, 4	7.250 Picograms per milliliter
400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	8 minutes; n=7, 2, 2, 5, 1, 4	145.500 Picograms per milliliter
400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	30 minutes; n=7, 4, 2, 5, 1, 4	100.500 Picograms per milliliter
400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	20 minutes; n=7, 4, 2, 5, 1, 4	128.510 Picograms per milliliter
400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	5 minutes; n=7, 3, 2, 5, 1, 4	167.250 Picograms per milliliter
400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	1 Hour; n=7, 4, 2, 5, 1, 4	32.980 Picograms per milliliter
400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	10 minutes; n=7, 4, 2, 5, 1, 4	142.900 Picograms per milliliter
400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	-1 hour; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	15 minutes; n=7, 4, 2, 5, 1, 4	131.970 Picograms per milliliter
17 mcg Oxytocin IM	Part 2: Plasma Concentration Time Profile of Oxytocin.	15 minutes; n=7, 4, 2, 5, 1, 4	197.855 Picograms per milliliter
17 mcg Oxytocin IM	Part 2: Plasma Concentration Time Profile of Oxytocin.	8 minutes; n=7, 2, 2, 5, 1, 4	456.100 Picograms per milliliter
17 mcg Oxytocin IM	Part 2: Plasma Concentration Time Profile of Oxytocin.	-15 minutes; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
17 mcg Oxytocin IM	Part 2: Plasma Concentration Time Profile of Oxytocin.	3 Hours; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
17 mcg Oxytocin IM	Part 2: Plasma Concentration Time Profile of Oxytocin.	10 minutes; n=7, 4, 2, 5, 1, 4	345.845 Picograms per milliliter
17 mcg Oxytocin IM	Part 2: Plasma Concentration Time Profile of Oxytocin.	-30 minutes; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
17 mcg Oxytocin IM	Part 2: Plasma Concentration Time Profile of Oxytocin.	2 Hours; n=7, 4, 2, 5, 1, 4	2.885 Picograms per milliliter
17 mcg Oxytocin IM	Part 2: Plasma Concentration Time Profile of Oxytocin.	2.5 Hours; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
17 mcg Oxytocin IM	Part 2: Plasma Concentration Time Profile of Oxytocin.	-1 hour; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
17 mcg Oxytocin IM	Part 2: Plasma Concentration Time Profile of Oxytocin.	4 Hours; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
17 mcg Oxytocin IM	Part 2: Plasma Concentration Time Profile of Oxytocin.	2 minutes; n=7, 3, 2, 5, 1, 4	1081.270 Picograms per milliliter
17 mcg Oxytocin IM	Part 2: Plasma Concentration Time Profile of Oxytocin.	3 minutes; n=7, 3, 2, 5, 1, 4	1096.990 Picograms per milliliter
17 mcg Oxytocin IM	Part 2: Plasma Concentration Time Profile of Oxytocin.	1.5 Hours; n=7, 4, 2, 5, 1, 4	5.580 Picograms per milliliter
17 mcg Oxytocin IM	Part 2: Plasma Concentration Time Profile of Oxytocin.	30 minutes; n=7, 4, 2, 5, 1, 4	63.485 Picograms per milliliter
17 mcg Oxytocin IM	Part 2: Plasma Concentration Time Profile of Oxytocin.	5 minutes; n=7, 3, 2, 5, 1, 4	627.240 Picograms per milliliter
17 mcg Oxytocin IM	Part 2: Plasma Concentration Time Profile of Oxytocin.	1 Hour; n=7, 4, 2, 5, 1, 4	15.095 Picograms per milliliter
17 mcg Oxytocin IM	Part 2: Plasma Concentration Time Profile of Oxytocin.	20 minutes; n=7, 4, 2, 5, 1, 4	128.060 Picograms per milliliter
17 mcg Oxytocin IM	Part 2: Plasma Concentration Time Profile of Oxytocin.	45 minutes; n=7, 4, 2, 5, 1, 4	29.290 Picograms per milliliter
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	30 minutes; n=7, 4, 2, 5, 1, 4	75.630 Picograms per milliliter
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	1 Hour; n=7, 4, 2, 5, 1, 4	22.145 Picograms per milliliter
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	1.5 Hours; n=7, 4, 2, 5, 1, 4	8.170 Picograms per milliliter
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	2 Hours; n=7, 4, 2, 5, 1, 4	2.960 Picograms per milliliter
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	-15 minutes; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	2 minutes; n=7, 3, 2, 5, 1, 4	219.930 Picograms per milliliter
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	-1 hour; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	3 minutes; n=7, 3, 2, 5, 1, 4	496.705 Picograms per milliliter
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	5 minutes; n=7, 3, 2, 5, 1, 4	697.740 Picograms per milliliter
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	3 Hours; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	8 minutes; n=7, 2, 2, 5, 1, 4	554.120 Picograms per milliliter
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	10 minutes; n=7, 4, 2, 5, 1, 4	422.745 Picograms per milliliter
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	15 minutes; n=7, 4, 2, 5, 1, 4	228.795 Picograms per milliliter
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	-30 minutes; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	20 minutes; n=7, 4, 2, 5, 1, 4	146.675 Picograms per milliliter
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	2.5 Hours; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	45 minutes; n=7, 4, 2, 5, 1, 4	34.125 Picograms per milliliter
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	4 Hours; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	5 minutes; n=7, 3, 2, 5, 1, 4	364.740 Picograms per milliliter
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	3 Hours; n=7, 4, 2, 5, 1, 4	5.740 Picograms per milliliter
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	1 Hour; n=7, 4, 2, 5, 1, 4	84.240 Picograms per milliliter
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	20 minutes; n=7, 4, 2, 5, 1, 4	230.840 Picograms per milliliter
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	-30 minutes; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	2.5 Hours; n=7, 4, 2, 5, 1, 4	9.640 Picograms per milliliter
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	-1 hour; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	3 minutes; n=7, 3, 2, 5, 1, 4	345.610 Picograms per milliliter
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	2 minutes; n=7, 3, 2, 5, 1, 4	274.840 Picograms per milliliter
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	30 minutes; n=7, 4, 2, 5, 1, 4	200.950 Picograms per milliliter
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	-15 minutes; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	45 minutes; n=7, 4, 2, 5, 1, 4	133.290 Picograms per milliliter
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	10 minutes; n=7, 4, 2, 5, 1, 4	319.960 Picograms per milliliter
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	8 minutes; n=7, 2, 2, 5, 1, 4	287.980 Picograms per milliliter
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	4 Hours; n=7, 4, 2, 5, 1, 4	2.910 Picograms per milliliter
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	2 Hours; n=7, 4, 2, 5, 1, 4	19.770 Picograms per milliliter
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	15 minutes; n=7, 4, 2, 5, 1, 4	250.260 Picograms per milliliter
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Plasma Concentration Time Profile of Oxytocin.	1.5 Hours; n=7, 4, 2, 5, 1, 4	41.270 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Plasma Concentration Time Profile of Oxytocin.	2.5 Hours; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Plasma Concentration Time Profile of Oxytocin.	-1 hour; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Plasma Concentration Time Profile of Oxytocin.	-30 minutes; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Plasma Concentration Time Profile of Oxytocin.	-15 minutes; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Plasma Concentration Time Profile of Oxytocin.	2 minutes; n=7, 3, 2, 5, 1, 4	727.660 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Plasma Concentration Time Profile of Oxytocin.	3 minutes; n=7, 3, 2, 5, 1, 4	1312.740 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Plasma Concentration Time Profile of Oxytocin.	5 minutes; n=7, 3, 2, 5, 1, 4	827.940 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Plasma Concentration Time Profile of Oxytocin.	8 minutes; n=7, 2, 2, 5, 1, 4	507.620 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Plasma Concentration Time Profile of Oxytocin.	10 minutes; n=7, 4, 2, 5, 1, 4	431.980 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Plasma Concentration Time Profile of Oxytocin.	15 minutes; n=7, 4, 2, 5, 1, 4	266.140 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Plasma Concentration Time Profile of Oxytocin.	20 minutes; n=7, 4, 2, 5, 1, 4	159.500 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Plasma Concentration Time Profile of Oxytocin.	30 minutes; n=7, 4, 2, 5, 1, 4	80.120 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Plasma Concentration Time Profile of Oxytocin.	45 minutes; n=7, 4, 2, 5, 1, 4	39.220 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Plasma Concentration Time Profile of Oxytocin.	1 Hour; n=7, 4, 2, 5, 1, 4	21.290 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Plasma Concentration Time Profile of Oxytocin.	1.5 Hours; n=7, 4, 2, 5, 1, 4	7.200 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Plasma Concentration Time Profile of Oxytocin.	2 Hours; n=7, 4, 2, 5, 1, 4	3.500 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Plasma Concentration Time Profile of Oxytocin.	3 Hours; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Plasma Concentration Time Profile of Oxytocin.	4 Hours; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	1 Hour; n=7, 4, 2, 5, 1, 4	15.495 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	45 minutes; n=7, 4, 2, 5, 1, 4	30.945 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	30 minutes; n=7, 4, 2, 5, 1, 4	65.560 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	20 minutes; n=7, 4, 2, 5, 1, 4	138.780 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	15 minutes; n=7, 4, 2, 5, 1, 4	234.745 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	2.5 Hours; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	10 minutes; n=7, 4, 2, 5, 1, 4	464.925 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	8 minutes; n=7, 2, 2, 5, 1, 4	560.665 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	5 minutes; n=7, 3, 2, 5, 1, 4	622.175 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	3 minutes; n=7, 3, 2, 5, 1, 4	539.615 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	4 Hours; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	3 Hours; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	2 minutes; n=7, 3, 2, 5, 1, 4	284.160 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	-15 minutes; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	-30 minutes; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	1.5 Hours; n=7, 4, 2, 5, 1, 4	5.160 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	-1 hour; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Plasma Concentration Time Profile of Oxytocin.	2 Hours; n=7, 4, 2, 5, 1, 4	2.460 Picograms per milliliter

Primary

Part 2: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin

Blood samples were collected at indicated time points to evaluate Tmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Arm	Measure	Value (MEDIAN)
400 mcg Oxytocin IH	Part 2: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin	0.08333 Hours
17 mcg Oxytocin IM	Part 2: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin	0.04167 Hours
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin	0.0833 Hours
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin	0.0833 Hours
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin	0.05000 Hours
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin	0.08333 Hours

Primary

Part 2: Time to Reach Terminal Phase Half-life (t1/2) of Oxytocin

Blood samples were collected at indicated time points to evaluate t1/2 of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Participants analysed (22) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Arm	Measure	Value (MEDIAN)
400 mcg Oxytocin IH	Part 2: Time to Reach Terminal Phase Half-life (t1/2) of Oxytocin	0.5523 Hours
17 mcg Oxytocin IM	Part 2: Time to Reach Terminal Phase Half-life (t1/2) of Oxytocin	0.3728 Hours
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Time to Reach Terminal Phase Half-life (t1/2) of Oxytocin	0.3525 Hours
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Time to Reach Terminal Phase Half-life (t1/2) of Oxytocin	0.6154 Hours
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus	Part 2: Time to Reach Terminal Phase Half-life (t1/2) of Oxytocin	0.357 Hours
Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion	Part 2: Time to Reach Terminal Phase Half-life (t1/2) of Oxytocin	0.3398 Hours

Primary

Part 2: Volume of Distribution (VOD) of Oxytocin for IV Route Only

Blood samples were collected at indicated time points to evaluate volume of distribution of oxytocin IV bolus and infusion. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Only IV reporting arms presented.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
400 mcg Oxytocin IH	Part 2: Volume of Distribution (VOD) of Oxytocin for IV Route Only	31.22 Liters	Geometric Coefficient of Variation 56.5
17 mcg Oxytocin IM	Part 2: Volume of Distribution (VOD) of Oxytocin for IV Route Only	25.50 Liters	Geometric Coefficient of Variation 7.8
Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion	Part 2: Volume of Distribution (VOD) of Oxytocin for IV Route Only	20.85 Liters	—
Non-Combined Oral Contraceptives+400 mcg Oxytocin IH	Part 2: Volume of Distribution (VOD) of Oxytocin for IV Route Only	23.47 Liters	Geometric Coefficient of Variation 27.4

Secondary

Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.

Time frame: 30 minutes and 2 hours post dose

Population: Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
400 mcg Oxytocin IH	Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 30 minutes; n=9, 8	114.2 Millimeters of mercury	Standard Deviation 10.35
400 mcg Oxytocin IH	Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 2 hours; n=9, 7	111.0 Millimeters of mercury	Standard Deviation 16.63
400 mcg Oxytocin IH	Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 30 minutes; n=9, 8	66.2 Millimeters of mercury	Standard Deviation 5.31
400 mcg Oxytocin IH	Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 2 hours; n=9, 7	65.1 Millimeters of mercury	Standard Deviation 8.48
17 mcg Oxytocin IM	Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 2 hours; n=9, 7	64.0 Millimeters of mercury	Standard Deviation 9.04
17 mcg Oxytocin IM	Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 30 minutes; n=9, 8	121.5 Millimeters of mercury	Standard Deviation 19.65
17 mcg Oxytocin IM	Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP: 30 minutes; n=9, 8	69.9 Millimeters of mercury	Standard Deviation 11.37
17 mcg Oxytocin IM	Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP: 2 hours; n=9, 7	110.0 Millimeters of mercury	Standard Deviation 10.21

Secondary

Part 1: Absolute Values of Heart Rate

Heart rate was measured in semi-supine position after 5 minutes rest

Time frame: 30 minutes and 2 hours post dose

Population: Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
400 mcg Oxytocin IH	Part 1: Absolute Values of Heart Rate	30 minutes; n= 9, 8	86.9 Beats per minute	Standard Deviation 19.85
400 mcg Oxytocin IH	Part 1: Absolute Values of Heart Rate	2 hours; n= 9, 7	86.0 Beats per minute	Standard Deviation 16.89
17 mcg Oxytocin IM	Part 1: Absolute Values of Heart Rate	30 minutes; n= 9, 8	86.4 Beats per minute	Standard Deviation 23.05
17 mcg Oxytocin IM	Part 1: Absolute Values of Heart Rate	2 hours; n= 9, 7	83.0 Beats per minute	Standard Deviation 11.27

Secondary

Part 1: Absolute Values of Respiration Rate

Respiration rate was measured in semi-supine position after 5 minutes rest

Time frame: 30 minutes and 2 hours post dose

Population: Safety Population. Only those participants with data available at specified data points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
400 mcg Oxytocin IH	Part 1: Absolute Values of Respiration Rate	30 minutes	14.4 Breaths per minute	Standard Deviation 2.55
400 mcg Oxytocin IH	Part 1: Absolute Values of Respiration Rate	2 hours	14.7 Breaths per minute	Standard Deviation 2.06
17 mcg Oxytocin IM	Part 1: Absolute Values of Respiration Rate	2 hours	14.1 Breaths per minute	Standard Deviation 2.19
17 mcg Oxytocin IM	Part 1: Absolute Values of Respiration Rate	30 minutes	14.6 Breaths per minute	Standard Deviation 3.15

Secondary

Part 1: Absolute Values of Temperature

Body temperature was measured in semi-supine position after 5 minutes rest

Time frame: 30 minutes and 2 hours post dose

Population: Safety Population. Only those participants with data available at specified data points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
400 mcg Oxytocin IH	Part 1: Absolute Values of Temperature	30 minutes	37.29 Degrees Celsius	Standard Deviation 0.699
400 mcg Oxytocin IH	Part 1: Absolute Values of Temperature	2 hours	37.03 Degrees Celsius	Standard Deviation 0.581
17 mcg Oxytocin IM	Part 1: Absolute Values of Temperature	30 minutes	36.69 Degrees Celsius	Standard Deviation 0.135
17 mcg Oxytocin IM	Part 1: Absolute Values of Temperature	2 hours	36.90 Degrees Celsius	Standard Deviation 0.173

Secondary

Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Three Hours (AUC ([0-3]) of Oxytocin

Blood samples were collected at indicated time points to evaluate AUC (0-3) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Time frame: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours and 3 hours post dose on Day 1

Population: Pharmacokinetic Population.

Arm	Measure	Value (MEAN)
400 mcg Oxytocin IH	Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Three Hours (AUC ([0-3]) of Oxytocin	NA Hour*picogram per milliliter
17 mcg Oxytocin IM	Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Three Hours (AUC ([0-3]) of Oxytocin	NA Hour*picogram per milliliter

Secondary

Part 1: Change From Baseline in Body Temperature

Body temperature was measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Time frame: Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose

Population: Safety Population. Only those participants with data available at specified data points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
400 mcg Oxytocin IH	Part 1: Change From Baseline in Body Temperature	30 minutes	0.60 Degrees Celsius	Standard Deviation 0.74
400 mcg Oxytocin IH	Part 1: Change From Baseline in Body Temperature	2 hours	0.34 Degrees Celsius	Standard Deviation 0.623
17 mcg Oxytocin IM	Part 1: Change From Baseline in Body Temperature	30 minutes	-0.01 Degrees Celsius	Standard Deviation 0.434
17 mcg Oxytocin IM	Part 1: Change From Baseline in Body Temperature	2 hours	0.20 Degrees Celsius	Standard Deviation 0.277

Secondary

Part 1: Change From Baseline in Heart Rate

Time frame: Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose

Population: Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
400 mcg Oxytocin IH	Part 1: Change From Baseline in Heart Rate	30 minutes; n= 9, 8	0.2 Beats per minute	Standard Deviation 16.41
400 mcg Oxytocin IH	Part 1: Change From Baseline in Heart Rate	2 hours; n=9, 7	-0.7 Beats per minute	Standard Deviation 10.39
17 mcg Oxytocin IM	Part 1: Change From Baseline in Heart Rate	30 minutes; n= 9, 8	4.8 Beats per minute	Standard Deviation 22.75
17 mcg Oxytocin IM	Part 1: Change From Baseline in Heart Rate	2 hours; n=9, 7	1.9 Beats per minute	Standard Deviation 9.81

Secondary

Part 1: Change From Baseline in Respiration Rate

Respiration rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Time frame: Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose

Population: Safety Population. Only those participants with data available at specified data points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
400 mcg Oxytocin IH	Part 1: Change From Baseline in Respiration Rate	30 minutes	0.3 Breaths per minute	Standard Deviation 2.12
400 mcg Oxytocin IH	Part 1: Change From Baseline in Respiration Rate	2 hours	0.6 Breaths per minute	Standard Deviation 2.24
17 mcg Oxytocin IM	Part 1: Change From Baseline in Respiration Rate	30 minutes	-0.3 Breaths per minute	Standard Deviation 2.75
17 mcg Oxytocin IM	Part 1: Change From Baseline in Respiration Rate	2 hours	-0.7 Breaths per minute	Standard Deviation 1.89

Secondary

Part 1: Change From Baseline in SBP and DBP

Time frame: Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose

Population: Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
400 mcg Oxytocin IH	Part 1: Change From Baseline in SBP and DBP	SBP: 30 minutes; n= 9, 8	0.1 Millimeters of mercury	Standard Deviation 8.39
400 mcg Oxytocin IH	Part 1: Change From Baseline in SBP and DBP	SBP: 2 hours; n=9, 7	-3.1 Millimeters of mercury	Standard Deviation 13.27
400 mcg Oxytocin IH	Part 1: Change From Baseline in SBP and DBP	DBP: 30 minutes; n= 9, 8	-4.0 Millimeters of mercury	Standard Deviation 11.14
400 mcg Oxytocin IH	Part 1: Change From Baseline in SBP and DBP	DBP: 2 hours; n=9, 7	-5.1 Millimeters of mercury	Standard Deviation 10.43
17 mcg Oxytocin IM	Part 1: Change From Baseline in SBP and DBP	DBP: 2 hours; n=9, 7	-6.0 Millimeters of mercury	Standard Deviation 11.47
17 mcg Oxytocin IM	Part 1: Change From Baseline in SBP and DBP	SBP: 30 minutes; n= 9, 8	11.4 Millimeters of mercury	Standard Deviation 17.48
17 mcg Oxytocin IM	Part 1: Change From Baseline in SBP and DBP	DBP: 30 minutes; n= 9, 8	-0.1 Millimeters of mercury	Standard Deviation 13.17
17 mcg Oxytocin IM	Part 1: Change From Baseline in SBP and DBP	SBP: 2 hours; n=9, 7	-0.9 Millimeters of mercury	Standard Deviation 13.21

Secondary

Part 1: Number of Participants With Non-SAEs and SAEs

An adverse event is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function.

Time frame: Up to 15 days

Population: Safety Population includes participants who received at least one dose of study medication

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
400 mcg Oxytocin IH	Part 1: Number of Participants With Non-SAEs and SAEs	Any non-SAE	3 Participants
400 mcg Oxytocin IH	Part 1: Number of Participants With Non-SAEs and SAEs	Any SAE	2 Participants
17 mcg Oxytocin IM	Part 1: Number of Participants With Non-SAEs and SAEs	Any non-SAE	2 Participants
17 mcg Oxytocin IM	Part 1: Number of Participants With Non-SAEs and SAEs	Any SAE	2 Participants

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026

Comparison of Inhaled Oxytocin (IH) With Intramuscular (IM) Oxytocin in Pregnant Women and With Intravenous (IV) Oxytocin in Healthy Non-pregnant Women

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Part 1: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Oxytocin

Part 1: Maximum Observed Plasma Concentration (Cmax) of Oxytocin

Part 1: Observed Plasma Concentration (Cp) 10 of Oxytocin

Part 1: Observed Plasma Concentration (Cp) 20 of Oxytocin

Part 1: Observed Plasma Concentration (Cp) 30 of Oxytocin

Part 1: Plasma Concentration Time Profile of Oxytocin

Part 1: Terminal Phase Half-life (t1/2) of Oxytocin

Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin

Part 2: Absolute Values of Heart Rate

Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval

Part 2: Absolute Values of Respiration Rate

Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Part 2: Area Under the Concentration-time Curve From Time Zero Extrapolated to Time 't' (AUC[0-t]) of Oxytocin

Part 2: Change From Baseline in Heart Rate

Part 2: Change From Baseline in SBP and DBP

Part 2: Forced Expiratory Volume at 1 Minute (FEV1)

Part 2: Maximum Observed Plasma Concentration (Cmax) of Oxytocin

Part 2: Number of Participants With Abnormal Respiratory Events

Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)

Part 2: Observed Plasma Concentration (Cp)10 of Oxytocin

Part 2: Observed Plasma Concentration (Cp)20 of Oxytocin

Part 2: Observed Plasma Concentration (Cp)30 of Oxytocin

Part 2: Percent Oxygen in Blood

Part 2: Plasma Clearance (CL) of Oxytocin for IV Route Only

Part 2: Plasma Concentration Time Profile of Oxytocin.

Part 2: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin

Part 2: Time to Reach Terminal Phase Half-life (t1/2) of Oxytocin

Part 2: Volume of Distribution (VOD) of Oxytocin for IV Route Only

Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Part 1: Absolute Values of Heart Rate

Part 1: Absolute Values of Respiration Rate

Part 1: Absolute Values of Temperature

Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Three Hours (AUC ([0-3]) of Oxytocin

Part 1: Change From Baseline in Body Temperature

Part 1: Change From Baseline in Heart Rate

Part 1: Change From Baseline in Respiration Rate

Part 1: Change From Baseline in SBP and DBP

Part 1: Number of Participants With Non-SAEs and SAEs