OxyNorm® Capsules (Immediate-Release) Pharmacokinetic (PK) Study

OxyNorm® Capsules (Immediate-Release) PK Study

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01643772

Enrollment

Registered

2012-07-18

Start date

2011-05-31

Completion date

2012-07-31

Last updated

2019-10-21

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

Conditions

Pain

Brief summary

A Single Dose PK Study of OxyNorm® immediate-release capsules 5, 10, and 20mg, and a multiple-dose PK Study of OxyNorm® immediate-release capsules 10mg in Chinese patients with pain.It will be a single center, open label, randomized, oral administration study.

Detailed description

Single dose: The subjects will be randomized to receive a single dose of OxyNorm® immediate-release capsules 5, 10, and 20mg. Multiple dose: The subjects will take 3 days OxyNorm® capsule 10mg, once every 6 hours, 10mg per dose. In the morning of the 4th day, the subjects will take single dose of OxyNorm® capsule 10mg. On the 5th day, all the subjects complete the study.

Interventions

DRUGOxycodone hydrochloride

The subjects will be randomized to receive either a single dose of OxyNorm® Capsules 5, 10, 20mg, or multiple-dose OxyNorm® Capsules 10 mg for 13 times.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Patients with pain, Multiple dose group should enroll the Patients with cancer pain; * Patients aged \>≥30 to ≤ 60 years; * Body weight ≥ 45kg, and BMI range ≥19, \<24; * Karnofsky score ≥ 70; * The results of liver function and kidney tests must meet the following criteria: ALT、AST is within the upper limit of normal value ranges by a factor 2, and TB、BUN、Cr is within the upper limit of normal value ranges by a factor 1.25; * The electrocardiogram examination results are normal; * Patients must have given a written informed consent prior to this trial, and have the capability to complete every required test.

Exclusion criteria

* Have hypersensitivity history to any opioids; * Have known hypersensitivity to any of compositions of the study drugs; * Patients who are likely to have paralytic ileus or acute abdomen or to perform an operation on abdominal region； * Patients with respiratory depression, cor pulmonale, or chronic bronchial asthma; * Patients who are unable to stop taking monoamine oxidase inhibitor during this trial period or time lapses less than 2 weeks since drug withdrawal; * Patients with hypercarbia; * Patients with biliary tract diseases, pancreatitis, prostatic hypertrophy, or corticoadrenal insufficiency; * Patients with alcoholism or drug abuse history; * Positive anti-HIV or syphilis antibody test result; * Patients who are pregnant, or lactating; * Urine screening before study is positive for opioids, barbiturates, amphetamines, cocaine metabolites, methadone, diazepam and cannabinoids; * Donated 400 mL or more of blood or blood products within 3 months prior to the start of the study, or donated 200 mL or more of blood or blood products within one month prior to the start of the study; * Subjects who participated in a clinical research study within one month of study entry; * Patients who are currently taking opioids.

Design outcomes

Primary

Measure	Time frame	Description
AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.	To calculate AUC0-t AUC0-∞of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method.Plasma concentrations of Oxycodone Hydrochloride single dose 5mg,10mg,20mg will be analyzed.
Cmax,Clast for Participants Who Received a Single Dose	blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.	To calculate Cmax,Clast of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.
Tmax,t1/2 for Participants Who Received a Single Dose	blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.	To calculate Tmax,t1/2 of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.
Clearance Rate for Participants Who Received a Single Dose	blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.	To calculate CL of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.
Vd for Participants Who Received a Single Dose	blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.	To calculate Apparent Distribution Volume (Vd) Vd of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.
ke for Participants Who Received a Single Dose	blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.	To calculate Terminal Elimination Rate (ke) of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.
AUCss for Participants Who Received Multiple Dose	Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.	To calculate AUCss of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.
Css_min,Css_max and Css_av for Participants Who Received Multiple Dose	Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.	To calculate Css\_min,Css\_max and Css\_av of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.
Tmax,t1/2 for Participants Who Received Multiple Dose	Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.	To calculate Tmax,t1/2 of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.
CL for Participants Who Received Multiple Dose	Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.	To calculate Clearance rate (CL) of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.
Fluctuation Index (DF) for Participants Who Received Multiple Dose	Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.	To calculate Fluctuation index (DF) of Drug Valley and Peak Concentration of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h	The excretion of drugs were calculated according to the concentration and volume of drugs in urine after single dose.
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h	Cumulative excretion of drugs were calculated according to the concentration and volume of drugs in urine after single dose.
Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	post dose 24h	Average cumulative excretion rate of drugs were calculated according to the concentration and volume of drugs in urine after single dose.
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th day	The excretion of drugs were calculated according to the concentration and volume of drugs in urine after multiple dose on the 4th day.
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th day	Cumulative excretion of drugs were calculated according to the concentration and volume of drugs in urine after multiple dose on the 4th day .

Countries

China

Participant flow

Recruitment details

The study was conducted in phase I unit in two public hospitals, the first subject took the first dose study medication on 13May2011, the last subject took the last dose on 6Jul2012.

Pre-assignment details

The study has a 7-days screening phase, for the subject who meet all the inclusion and exclusion criteria was dosed without run-in or wash out period.

Participants by arm

Arm	Count
Oxycodone Hydrochloride Single Dose(5mg) Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting	15
Oxycodone Hydrochloride Single Dose(10mg) Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting	15
Oxycodone Hydrochloride Single Dose(20mg) Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting	15
Oxycodone Hydrochloride Multiple Dose(10mg) Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning	16
Total	61

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Adverse Event	0	0	0	1
Overall Study	Protocol Violation	0	0	0	1

Baseline characteristics

Characteristic	Oxycodone Hydrochloride Single Dose(5mg)	Total	Oxycodone Hydrochloride Multiple Dose(10mg)	Oxycodone Hydrochloride Single Dose(20mg)	Oxycodone Hydrochloride Single Dose(10mg)
Age, Continuous	40.22 year STANDARD_DEVIATION 4.9	41.11 year STANDARD_DEVIATION 8.14	48.62 year STANDARD_DEVIATION 7.87	36.16 year STANDARD_DEVIATION 8.68	39.63 year STANDARD_DEVIATION 6.21
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	15 Participants	58 Participants	14 Participants	14 Participants	15 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Region of Enrollment China	15 participants	61 participants	14 participants	14 participants	15 participants
Sex: Female, Male Female	8 Participants	28 Participants	7 Participants	5 Participants	8 Participants
Sex: Female, Male Male	7 Participants	30 Participants	7 Participants	9 Participants	7 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 15	0 / 15	0 / 15	0 / 16
other Total, other adverse events	8 / 15	11 / 15	14 / 15	12 / 16
serious Total, serious adverse events	0 / 15	0 / 15	0 / 15	0 / 16

Outcome results

Primary

AUC0-t and AUC0-∞ for Participants Who Received a Single Dose

To calculate AUC0-t AUC0-∞of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method.Plasma concentrations of Oxycodone Hydrochloride single dose 5mg,10mg,20mg will be analyzed.

Time frame: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

Population: PP Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Oxycodone Hydrochloride Single Dose 5 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Noroxycodone(AUC0-t)	38.85 nghrml	Standard Deviation 9.61
Oxycodone Hydrochloride Single Dose 5 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Normethoxymorphone(AUC0-∞)	15.07 nghrml	Standard Deviation 11.54
Oxycodone Hydrochloride Single Dose 5 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Hydroxymorphine(AUC0-∞)	0 nghrml	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 5 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Noroxycodone(AUC0-∞)	41.93 nghrml	Standard Deviation 11.09
Oxycodone Hydrochloride Single Dose 5 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Oxycondone(AUC0-∞)	58.38 nghrml	Standard Deviation 15.41
Oxycodone Hydrochloride Single Dose 5 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Oxycondone(AUC0-t)	57.03 nghrml	Standard Deviation 14.62
Oxycodone Hydrochloride Single Dose 5 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Normethoxymorphone(AUC0-t)	13.27 nghrml	Standard Deviation 10.43
Oxycodone Hydrochloride Single Dose 10 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Hydroxymorphine(AUC0-t)	3.12 nghrml	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 10 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Oxycondone(AUC0-t)	102.10 nghrml	Standard Deviation 23.94
Oxycodone Hydrochloride Single Dose 10 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Oxycondone(AUC0-∞)	104.56 nghrml	Standard Deviation 25.16
Oxycodone Hydrochloride Single Dose 10 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Noroxycodone(AUC0-t)	89.76 nghrml	Standard Deviation 29.13
Oxycodone Hydrochloride Single Dose 10 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Noroxycodone(AUC0-∞)	99.15 nghrml	Standard Deviation 34.11
Oxycodone Hydrochloride Single Dose 10 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Hydroxymorphine(AUC0-∞)	3.96 nghrml	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 10 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Normethoxymorphone(AUC0-t)	28.69 nghrml	Standard Deviation 26.39
Oxycodone Hydrochloride Single Dose 10 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Normethoxymorphone(AUC0-∞)	33.31 nghrml	Standard Deviation 29.29
Oxycodone Hydrochloride Single Dose 20 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Oxycondone(AUC0-t)	205.89 nghrml	Standard Deviation 58.03
Oxycodone Hydrochloride Single Dose 20 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Hydroxymorphine(AUC0-∞)	4.36 nghrml	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 20 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Oxycondone(AUC0-∞)	210.61 nghrml	Standard Deviation 59.89
Oxycodone Hydrochloride Single Dose 20 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Normethoxymorphone(AUC0-∞)	43.85 nghrml	Standard Deviation 19.42
Oxycodone Hydrochloride Single Dose 20 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Normethoxymorphone(AUC0-t)	37.64 nghrml	Standard Deviation 17.51
Oxycodone Hydrochloride Single Dose 20 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Noroxycodone(AUC0-∞)	178.61 nghrml	Standard Deviation 46.7
Oxycodone Hydrochloride Single Dose 20 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Hydroxymorphine(AUC0-t)	3.79 nghrml	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 20 mg	AUC0-t and AUC0-∞ for Participants Who Received a Single Dose	Noroxycodone(AUC0-t)	163.68 nghrml	Standard Deviation 43.29

Primary

AUCss for Participants Who Received Multiple Dose

To calculate AUCss of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.

Time frame: Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.

Population: PP population

Arm	Measure	Group	Value (MEAN)	Dispersion
Oxycodone Hydrochloride Single Dose 5 mg	AUCss for Participants Who Received Multiple Dose	Oxycodone	156.03 nghoursmL	Standard Deviation 72.07
Oxycodone Hydrochloride Single Dose 5 mg	AUCss for Participants Who Received Multiple Dose	Noroxycodone	122.69 nghoursmL	Standard Deviation 39.02
Oxycodone Hydrochloride Single Dose 5 mg	AUCss for Participants Who Received Multiple Dose	Hydroxymorphine	4.51 nghoursmL	Standard Deviation 1.4
Oxycodone Hydrochloride Single Dose 5 mg	AUCss for Participants Who Received Multiple Dose	Normethoxymorphone	16.56 nghoursmL	Standard Deviation 8.34

Primary

Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)

Average cumulative excretion rate of drugs were calculated according to the concentration and volume of drugs in urine after single dose.

Time frame: post dose 24h

Arm	Measure	Group	Value (MEAN)	Dispersion
Oxycodone Hydrochloride Single Dose 5 mg	Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone	5.02 % of ug	Standard Deviation 3.98
Oxycodone Hydrochloride Single Dose 5 mg	Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone	9.50 % of ug	Standard Deviation 4.64
Oxycodone Hydrochloride Single Dose 5 mg	Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine	0.15 % of ug	Standard Deviation 0.14
Oxycodone Hydrochloride Single Dose 5 mg	Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone	2.00 % of ug	Standard Deviation 1.52
Oxycodone Hydrochloride Single Dose 10 mg	Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone	1.60 % of ug	Standard Deviation 1.84
Oxycodone Hydrochloride Single Dose 10 mg	Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone	5.11 % of ug	Standard Deviation 4.62
Oxycodone Hydrochloride Single Dose 10 mg	Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine	0.14 % of ug	Standard Deviation 0.17
Oxycodone Hydrochloride Single Dose 10 mg	Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone	11.70 % of ug	Standard Deviation 7.04
Oxycodone Hydrochloride Single Dose 20 mg	Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone	0.85 % of ug	Standard Deviation 0.37
Oxycodone Hydrochloride Single Dose 20 mg	Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone	11.40 % of ug	Standard Deviation 4.68
Oxycodone Hydrochloride Single Dose 20 mg	Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine	0.12 % of ug	Standard Deviation 0.08
Oxycodone Hydrochloride Single Dose 20 mg	Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone	3.65 % of ug	Standard Deviation 1.72

Primary

Clearance Rate for Participants Who Received a Single Dose

To calculate CL of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.

Time frame: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

Population: PP popuplation

Arm	Measure	Group	Value (MEAN)	Dispersion
Oxycodone Hydrochloride Single Dose 5 mg	Clearance Rate for Participants Who Received a Single Dose	Oxycodone (CL)	91.49 L*hour	Standard Deviation 24.45
Oxycodone Hydrochloride Single Dose 5 mg	Clearance Rate for Participants Who Received a Single Dose	Normethoxymorphone(CL)	443.45 L*hour	Standard Deviation 192.68
Oxycodone Hydrochloride Single Dose 5 mg	Clearance Rate for Participants Who Received a Single Dose	Noroxycodone (CL)	125.78 L*hour	Standard Deviation 28.4
Oxycodone Hydrochloride Single Dose 10 mg	Clearance Rate for Participants Who Received a Single Dose	Hydroxymorphine(CL)	2525.30 L*hour	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 10 mg	Clearance Rate for Participants Who Received a Single Dose	Noroxycodone (CL)	113.30 L*hour	Standard Deviation 40.85
Oxycodone Hydrochloride Single Dose 10 mg	Clearance Rate for Participants Who Received a Single Dose	Oxycodone (CL)	101.53 L*hour	Standard Deviation 27.54
Oxycodone Hydrochloride Single Dose 10 mg	Clearance Rate for Participants Who Received a Single Dose	Normethoxymorphone(CL)	530.65 L*hour	Standard Deviation 368.02
Oxycodone Hydrochloride Single Dose 20 mg	Clearance Rate for Participants Who Received a Single Dose	Normethoxymorphone(CL)	681.64 L*hour	Standard Deviation 736.51
Oxycodone Hydrochloride Single Dose 20 mg	Clearance Rate for Participants Who Received a Single Dose	Oxycodone (CL)	101.33 L*hour	Standard Deviation 25.16
Oxycodone Hydrochloride Single Dose 20 mg	Clearance Rate for Participants Who Received a Single Dose	Noroxycodone (CL)	119.38 L*hour	Standard Deviation 31.09
Oxycodone Hydrochloride Single Dose 20 mg	Clearance Rate for Participants Who Received a Single Dose	Hydroxymorphine(CL)	4587.50 L*hour	Standard Deviation 0

Primary

CL for Participants Who Received Multiple Dose

To calculate Clearance rate (CL) of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.

Time frame: Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.

Population: multiple dose group has 14 subjects

Arm	Measure	Group	Value (MEAN)	Dispersion
Oxycodone Hydrochloride Single Dose 5 mg	CL for Participants Who Received Multiple Dose	Oxycodone	73.54 L*hour	Standard Deviation 24.08
Oxycodone Hydrochloride Single Dose 5 mg	CL for Participants Who Received Multiple Dose	Noroxycodone	90.66 L*hour	Standard Deviation 32.56
Oxycodone Hydrochloride Single Dose 5 mg	CL for Participants Who Received Multiple Dose	Hydroxymorphine	2374.20 L*hour	Standard Deviation 597.75
Oxycodone Hydrochloride Single Dose 5 mg	CL for Participants Who Received Multiple Dose	Normethoxymorphone	773.01 L*hour	Standard Deviation 431.19

Primary

Cmax,Clast for Participants Who Received a Single Dose

To calculate Cmax,Clast of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.

Time frame: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

Population: PP population

Arm	Measure	Group	Value (MEAN)	Dispersion
Oxycodone Hydrochloride Single Dose 5 mg	Cmax,Clast for Participants Who Received a Single Dose	Normethoxymorphone(Clast)	0.16 ng*mL	Standard Deviation 0.12
Oxycodone Hydrochloride Single Dose 5 mg	Cmax,Clast for Participants Who Received a Single Dose	Hydroxymorphine(Cmax)	0.27 ng*mL	Standard Deviation 0.12
Oxycodone Hydrochloride Single Dose 5 mg	Cmax,Clast for Participants Who Received a Single Dose	Oxycodone(Clast)	0.20 ng*mL	Standard Deviation 0.11
Oxycodone Hydrochloride Single Dose 5 mg	Cmax,Clast for Participants Who Received a Single Dose	Oxycodone(Cmax)	12.97 ng*mL	Standard Deviation 2.67
Oxycodone Hydrochloride Single Dose 5 mg	Cmax,Clast for Participants Who Received a Single Dose	Normethoxymorphone(Cmax)	1.64 ng*mL	Standard Deviation 1.52
Oxycodone Hydrochloride Single Dose 5 mg	Cmax,Clast for Participants Who Received a Single Dose	Noroxycodone(Cmax)	6.19 ng*mL	Standard Deviation 2.15
Oxycodone Hydrochloride Single Dose 5 mg	Cmax,Clast for Participants Who Received a Single Dose	Noroxycodone(Clast)	0.32 ng*mL	Standard Deviation 0.17
Oxycodone Hydrochloride Single Dose 10 mg	Cmax,Clast for Participants Who Received a Single Dose	Normethoxymorphone(Cmax)	1.77 ng*mL	Standard Deviation 1.46
Oxycodone Hydrochloride Single Dose 10 mg	Cmax,Clast for Participants Who Received a Single Dose	Oxycodone(Cmax)	21.14 ng*mL	Standard Deviation 4.58
Oxycodone Hydrochloride Single Dose 10 mg	Cmax,Clast for Participants Who Received a Single Dose	Noroxycodone(Clast)	0.89 ng*mL	Standard Deviation 0.51
Oxycodone Hydrochloride Single Dose 10 mg	Cmax,Clast for Participants Who Received a Single Dose	Hydroxymorphine(Clast)	0.05 ng*mL	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 10 mg	Cmax,Clast for Participants Who Received a Single Dose	Normethoxymorphone(Clast)	0.36 ng*mL	Standard Deviation 0.28
Oxycodone Hydrochloride Single Dose 10 mg	Cmax,Clast for Participants Who Received a Single Dose	Noroxycodone(Cmax)	11.62 ng*mL	Standard Deviation 2.79
Oxycodone Hydrochloride Single Dose 10 mg	Cmax,Clast for Participants Who Received a Single Dose	Oxycodone(Clast)	0.37 ng*mL	Standard Deviation 0.2
Oxycodone Hydrochloride Single Dose 10 mg	Cmax,Clast for Participants Who Received a Single Dose	Hydroxymorphine(Cmax)	0.42 ng*mL	Standard Deviation 0.2
Oxycodone Hydrochloride Single Dose 20 mg	Cmax,Clast for Participants Who Received a Single Dose	Normethoxymorphone(Clast)	0.49 ng*mL	Standard Deviation 0.25
Oxycodone Hydrochloride Single Dose 20 mg	Cmax,Clast for Participants Who Received a Single Dose	Oxycodone(Cmax)	35.56 ng*mL	Standard Deviation 14.18
Oxycodone Hydrochloride Single Dose 20 mg	Cmax,Clast for Participants Who Received a Single Dose	Noroxycodone(Cmax)	19.19 ng*mL	Standard Deviation 5.88
Oxycodone Hydrochloride Single Dose 20 mg	Cmax,Clast for Participants Who Received a Single Dose	Hydroxymorphine(Cmax)	0.76 ng*mL	Standard Deviation 0.29
Oxycodone Hydrochloride Single Dose 20 mg	Cmax,Clast for Participants Who Received a Single Dose	Oxycodone(Clast)	0.74 ng*mL	Standard Deviation 0.3
Oxycodone Hydrochloride Single Dose 20 mg	Cmax,Clast for Participants Who Received a Single Dose	Noroxycodone(Clast)	1.56 ng*mL	Standard Deviation 0.47
Oxycodone Hydrochloride Single Dose 20 mg	Cmax,Clast for Participants Who Received a Single Dose	Hydroxymorphine(Clast)	0.05 ng*mL	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 20 mg	Cmax,Clast for Participants Who Received a Single Dose	Normethoxymorphone(Cmax)	3.52 ng*mL	Standard Deviation 1.75

Primary

Css_min,Css_max and Css_av for Participants Who Received Multiple Dose

To calculate Css\_min,Css\_max and Css\_av of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.

Time frame: Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.

Population: multiple dose group has 14 subjects

Arm	Measure	Group	Value (MEAN)	Dispersion
Oxycodone Hydrochloride Single Dose 5 mg	Css_min,Css_max and Css_av for Participants Who Received Multiple Dose	Oxycodone(Css_min)	16.92 ng/ml	Standard Deviation 8.71
Oxycodone Hydrochloride Single Dose 5 mg	Css_min,Css_max and Css_av for Participants Who Received Multiple Dose	Noroxycodone(Css_min)	15.74 ng/ml	Standard Deviation 5.58
Oxycodone Hydrochloride Single Dose 5 mg	Css_min,Css_max and Css_av for Participants Who Received Multiple Dose	Hydroxymorphine(Css_min)	0.40 ng/ml	Standard Deviation 0.2
Oxycodone Hydrochloride Single Dose 5 mg	Css_min,Css_max and Css_av for Participants Who Received Multiple Dose	Normethoxymorphone(Css_min)	2.18 ng/ml	Standard Deviation 1.02
Oxycodone Hydrochloride Single Dose 5 mg	Css_min,Css_max and Css_av for Participants Who Received Multiple Dose	Oxycodone(Css_max )	40.17 ng/ml	Standard Deviation 15.38
Oxycodone Hydrochloride Single Dose 5 mg	Css_min,Css_max and Css_av for Participants Who Received Multiple Dose	Noroxycodone(Css_max )	26.71 ng/ml	Standard Deviation 8.03
Oxycodone Hydrochloride Single Dose 5 mg	Css_min,Css_max and Css_av for Participants Who Received Multiple Dose	Hydroxymorphine(Css_max )	1.10 ng/ml	Standard Deviation 0.47
Oxycodone Hydrochloride Single Dose 5 mg	Css_min,Css_max and Css_av for Participants Who Received Multiple Dose	Normethoxymorphone(Css_max )	3.65 ng/ml	Standard Deviation 1.97
Oxycodone Hydrochloride Single Dose 5 mg	Css_min,Css_max and Css_av for Participants Who Received Multiple Dose	Oxycodone(Css_av)	26.01 ng/ml	Standard Deviation 12.01
Oxycodone Hydrochloride Single Dose 5 mg	Css_min,Css_max and Css_av for Participants Who Received Multiple Dose	Noroxycodone(Css_av)	20.44 ng/ml	Standard Deviation 6.5
Oxycodone Hydrochloride Single Dose 5 mg	Css_min,Css_max and Css_av for Participants Who Received Multiple Dose	Hydroxymorphine(Css_av)	0.75 ng/ml	Standard Deviation 0.24
Oxycodone Hydrochloride Single Dose 5 mg	Css_min,Css_max and Css_av for Participants Who Received Multiple Dose	Normethoxymorphone(Css_av)	2.76 ng/ml	Standard Deviation 1.39

Primary

Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)

Cumulative excretion of drugs were calculated according to the concentration and volume of drugs in urine after multiple dose on the 4th day .

Time frame: post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th day

Arm	Measure	Group	Value (MEAN)	Dispersion
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Oxycondone(post dose0-2h)	263.32 μg	Standard Deviation 236.25
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Oxycondone(post dose2-4h)	605.96 μg	Standard Deviation 479.83
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Oxycondone(post dose4-8h)	1037.66 μg	Standard Deviation 985.45
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Oxycondone(post dose8-12h)	913.59 μg	Standard Deviation 374.77
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Oxycondone(post dose12-24h)	1290.63 μg	Standard Deviation 720.65
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Noroxycodone(post dose0-2h)	372.51 μg	Standard Deviation 290.26
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Noroxycodone(post dose2-4h)	810.75 μg	Standard Deviation 419.08
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Noroxycodone(post dose4-8h)	1326.14 μg	Standard Deviation 645.18
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Noroxycodone(post dose8-12h)	1693.83 μg	Standard Deviation 978.49
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Noroxycodone(post dose12-24h)	2618.44 μg	Standard Deviation 1237.37
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Hydroxymorphine(post dose0-2h)	6.13 μg	Standard Deviation 8.11
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Hydroxymorphine(post dose2-4h)	30.16 μg	Standard Deviation 64.24
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Hydroxymorphine(post dose4-8h)	54.68 μg	Standard Deviation 67.67
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Hydroxymorphine(post dose8-12h)	72.85 μg	Standard Deviation 72.84
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Hydroxymorphine(post dose12-24h)	108.81 μg	Standard Deviation 77.11
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Normethoxymorphone(post dose0-2h)	130.63 μg	Standard Deviation 100.61
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Normethoxymorphone(post dose2-4h)	338.90 μg	Standard Deviation 241.5
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Normethoxymorphone(post dose4-8h)	601.46 μg	Standard Deviation 566.37
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Normethoxymorphone(post dose8-12h)	575.47 μg	Standard Deviation 287.77
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Normethoxymorphone(post dose12-24h)	796.81 μg	Standard Deviation 518.9

Primary

Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)

Cumulative excretion of drugs were calculated according to the concentration and volume of drugs in urine after single dose.

Time frame: post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h

Arm	Measure	Group	Value (MEAN)	Dispersion
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose12-24h)	7.64 μg	Standard Deviation 6.81
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose4-8h)	282.31 μg	Standard Deviation 192.38
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose0-2h)	25.69 μg	Standard Deviation 29.55
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose8-12h)	5.33 μg	Standard Deviation 4.83
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose8-12h)	421.75 μg	Standard Deviation 222.63
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose8-12h)	210.92 μg	Standard Deviation 203.25
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose4-8h)	3.27 μg	Standard Deviation 2.47
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose12-24h)	474.85 μg	Standard Deviation 232.06
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose12-24h)	99.87 μg	Standard Deviation 76.02
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose2-4h)	1.54 μg	Standard Deviation 1.56
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose0-2h)	0.51 μg	Standard Deviation 0.65
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose4-8h)	44.55 μg	Standard Deviation 44.62
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose12-24h)	251.22 μg	Standard Deviation 198.78
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose8-12h)	73.14 μg	Standard Deviation 58.19
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose2-4h)	19.40 μg	Standard Deviation 18.45
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose0-2h)	23.29 μg	Standard Deviation 39.94
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose4-8h)	154.86 μg	Standard Deviation 129.52
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose0-2h)	3.97 μg	Standard Deviation 6.96
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose2-4h)	128.82 μg	Standard Deviation 117.04
Oxycodone Hydrochloride Single Dose 5 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose2-4h)	89.93 μg	Standard Deviation 91.36
Oxycodone Hydrochloride Single Dose 10 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose4-8h)	99.55 μg	Standard Deviation 143.15
Oxycodone Hydrochloride Single Dose 10 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose0-2h)	54.55 μg	Standard Deviation 79.39
Oxycodone Hydrochloride Single Dose 10 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose2-4h)	226.92 μg	Standard Deviation 244.12
Oxycodone Hydrochloride Single Dose 10 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose4-8h)	396.20 μg	Standard Deviation 410.41
Oxycodone Hydrochloride Single Dose 10 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose8-12h)	474.68 μg	Standard Deviation 455.83
Oxycodone Hydrochloride Single Dose 10 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose12-24h)	510.80 μg	Standard Deviation 462.41
Oxycodone Hydrochloride Single Dose 10 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose0-2h)	63.80 μg	Standard Deviation 83.33
Oxycodone Hydrochloride Single Dose 10 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose2-4h)	410.02 μg	Standard Deviation 283.62
Oxycodone Hydrochloride Single Dose 10 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose4-8h)	828.97 μg	Standard Deviation 629
Oxycodone Hydrochloride Single Dose 10 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose8-12h)	1041.66 μg	Standard Deviation 699.41
Oxycodone Hydrochloride Single Dose 10 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose12-24h)	1170.41 μg	Standard Deviation 703.51
Oxycodone Hydrochloride Single Dose 10 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose0-2h)	0.94 μg	Standard Deviation 1.41
Oxycodone Hydrochloride Single Dose 10 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose2-4h)	3.46 μg	Standard Deviation 3.79
Oxycodone Hydrochloride Single Dose 10 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose4-8h)	9.27 μg	Standard Deviation 13.89
Oxycodone Hydrochloride Single Dose 10 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose8-12h)	12.24 μg	Standard Deviation 16.33
Oxycodone Hydrochloride Single Dose 10 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose12-24h)	13.91 μg	Standard Deviation 17.13
Oxycodone Hydrochloride Single Dose 10 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose0-2h)	7.16 μg	Standard Deviation 11.48
Oxycodone Hydrochloride Single Dose 10 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose2-4h)	30.68 μg	Standard Deviation 19.15
Oxycodone Hydrochloride Single Dose 10 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose8-12h)	129.72 μg	Standard Deviation 154.63
Oxycodone Hydrochloride Single Dose 10 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose12-24h)	159.88 μg	Standard Deviation 184.11
Oxycodone Hydrochloride Single Dose 20 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose2-4h)	424.64 μg	Standard Deviation 326.09
Oxycodone Hydrochloride Single Dose 20 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose8-12h)	21.22 μg	Standard Deviation 15.56
Oxycodone Hydrochloride Single Dose 20 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose2-4h)	942.44 μg	Standard Deviation 529.85
Oxycodone Hydrochloride Single Dose 20 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose12-24h)	170.60 μg	Standard Deviation 74.03
Oxycodone Hydrochloride Single Dose 20 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose12-24h)	24.11 μg	Standard Deviation 15.73
Oxycodone Hydrochloride Single Dose 20 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose0-2h)	157.75 μg	Standard Deviation 229.32
Oxycodone Hydrochloride Single Dose 20 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose8-12h)	136.84 μg	Standard Deviation 65.32
Oxycodone Hydrochloride Single Dose 20 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose0-2h)	8.53 μg	Standard Deviation 13.63
Oxycodone Hydrochloride Single Dose 20 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose12-24h)	729.07 μg	Standard Deviation 343.84
Oxycodone Hydrochloride Single Dose 20 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose0-2h)	108.57 μg	Standard Deviation 171.53
Oxycodone Hydrochloride Single Dose 20 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose2-4h)	48.82 μg	Standard Deviation 40.37
Oxycodone Hydrochloride Single Dose 20 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose8-12h)	661.15 μg	Standard Deviation 338.34
Oxycodone Hydrochloride Single Dose 20 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose0-2h)	2.89 μg	Standard Deviation 4.87
Oxycodone Hydrochloride Single Dose 20 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose12-24h)	2280.92 μg	Standard Deviation 936.47
Oxycodone Hydrochloride Single Dose 20 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose4-8h)	590.08 μg	Standard Deviation 361.27
Oxycodone Hydrochloride Single Dose 20 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose2-4h)	12.88 μg	Standard Deviation 10.4
Oxycodone Hydrochloride Single Dose 20 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose8-12h)	2015.62 μg	Standard Deviation 865.69
Oxycodone Hydrochloride Single Dose 20 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose4-8h)	88.46 μg	Standard Deviation 53.96
Oxycodone Hydrochloride Single Dose 20 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose4-8h)	18.73 μg	Standard Deviation 15.23
Oxycodone Hydrochloride Single Dose 20 mg	Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose4-8h)	1655.25 μg	Standard Deviation 736.42

Primary

Fluctuation Index (DF) for Participants Who Received Multiple Dose

To calculate Fluctuation index (DF) of Drug Valley and Peak Concentration of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.

Time frame: Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.

Population: multiple dose group has 14 subjects

Arm	Measure	Group	Value (MEAN)	Dispersion
Oxycodone Hydrochloride Single Dose 5 mg	Fluctuation Index (DF) for Participants Who Received Multiple Dose	Oxycodone	94.11 ng/ml	Standard Deviation 32.64
Oxycodone Hydrochloride Single Dose 5 mg	Fluctuation Index (DF) for Participants Who Received Multiple Dose	Noroxycodone	55.75 ng/ml	Standard Deviation 23.54
Oxycodone Hydrochloride Single Dose 5 mg	Fluctuation Index (DF) for Participants Who Received Multiple Dose	Hydroxymorphine	123.95 ng/ml	Standard Deviation 57.22
Oxycodone Hydrochloride Single Dose 5 mg	Fluctuation Index (DF) for Participants Who Received Multiple Dose	Normethoxymorphone	52.07 ng/ml	Standard Deviation 37.68

Primary

ke for Participants Who Received a Single Dose

To calculate Terminal Elimination Rate (ke) of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.

Time frame: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

Population: PP population

Arm	Measure	Group	Value (MEAN)	Dispersion
Oxycodone Hydrochloride Single Dose 5 mg	ke for Participants Who Received a Single Dose	Oxycodone	0.16 h^-1	Standard Deviation 0.03
Oxycodone Hydrochloride Single Dose 5 mg	ke for Participants Who Received a Single Dose	Normethoxymorphone	0.09 h^-1	Standard Deviation 0.02
Oxycodone Hydrochloride Single Dose 5 mg	ke for Participants Who Received a Single Dose	Noroxycodone	0.12 h^-1	Standard Deviation 0.02
Oxycodone Hydrochloride Single Dose 10 mg	ke for Participants Who Received a Single Dose	Hydroxymorphine	0.06 h^-1	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 10 mg	ke for Participants Who Received a Single Dose	Noroxycodone	0.11 h^-1	Standard Deviation 0.02
Oxycodone Hydrochloride Single Dose 10 mg	ke for Participants Who Received a Single Dose	Oxycodone	0.16 h^-1	Standard Deviation 0.02
Oxycodone Hydrochloride Single Dose 10 mg	ke for Participants Who Received a Single Dose	Normethoxymorphone	0.08 h^-1	Standard Deviation 0.02
Oxycodone Hydrochloride Single Dose 20 mg	ke for Participants Who Received a Single Dose	Normethoxymorphone	0.10 h^-1	Standard Deviation 0.05
Oxycodone Hydrochloride Single Dose 20 mg	ke for Participants Who Received a Single Dose	Oxycodone	0.17 h^-1	Standard Deviation 0.02
Oxycodone Hydrochloride Single Dose 20 mg	ke for Participants Who Received a Single Dose	Noroxycodone	0.11 h^-1	Standard Deviation 0.01
Oxycodone Hydrochloride Single Dose 20 mg	ke for Participants Who Received a Single Dose	Hydroxymorphine	0.09 h^-1	Standard Deviation 0

Primary

The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)

The excretion of drugs were calculated according to the concentration and volume of drugs in urine after multiple dose on the 4th day.

Time frame: Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th day

Arm	Measure	Group	Value (MEAN)	Dispersion
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Oxycondone(Pre-dose)	745.99 μg	Standard Deviation 1106.32
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Oxycondone(post dose0-2h)	263.32 μg	Standard Deviation 236.25
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Oxycondone(post dose2-4h)	342.64 μg	Standard Deviation 301.21
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Oxycondone(post dose4-8h)	431.70 μg	Standard Deviation 532.48
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Oxycondone(post dose8-12h)	137.13 μg	Standard Deviation 107.95
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Oxycondone(post dose12-24h)	344.15 μg	Standard Deviation 516.94
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Noroxycodone(Pre-dose)	897.44 μg	Standard Deviation 1121.8
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Noroxycodone(post dose0-2h)	372.51 μg	Standard Deviation 290.26
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Noroxycodone(post dose2-4h)	438.24 μg	Standard Deviation 218.9
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Noroxycodone(post dose4-8h)	515.39 μg	Standard Deviation 423.8
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Noroxycodone(post dose8-12h)	500.42 μg	Standard Deviation 717.43
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Noroxycodone(post dose12-24h)	865.37 μg	Standard Deviation 861.94
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Hydroxymorphine(Pre-dose)	9.43 μg	Standard Deviation 10.39
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Hydroxymorphine(post dose0-2h)	6.13 μg	Standard Deviation 8.11
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Hydroxymorphine(post dose2-4h)	24.03 μg	Standard Deviation 59.61
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Hydroxymorphine(post dose4-8h)	24.52 μg	Standard Deviation 27.45
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Hydroxymorphine(post dose8-12h)	15.10 μg	Standard Deviation 17.6
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Hydroxymorphine(post dose12-24h)	31.73 μg	Standard Deviation 36.65
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Normethoxymorphone(Pre-dose)	337.01 μg	Standard Deviation 460.24
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Normethoxymorphone(post dose0-2h)	130.63 μg	Standard Deviation 100.61
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Normethoxymorphone(post dose2-4h)	208.27 μg	Standard Deviation 183.64
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Normethoxymorphone(post dose4-8h)	262.56 μg	Standard Deviation 382.79
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Normethoxymorphone(post dose8-12h)	102.36 μg	Standard Deviation 91.74
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	Normethoxymorphone(post dose12-24h)	240.75 μg	Standard Deviation 332.72

Primary

The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)

The excretion of drugs were calculated according to the concentration and volume of drugs in urine after single dose.

Time frame: Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h

Arm	Measure	Group	Value (MEAN)	Dispersion
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(Pre-dose)	0 μg	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose0-2h)	25.69 μg	Standard Deviation 29.55
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose2-4h)	64.24 μg	Standard Deviation 72.4
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose4-8h)	64.93 μg	Standard Deviation 56.6
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose8-12h)	56.07 μg	Standard Deviation 84.81
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose12-24h)	40.30 μg	Standard Deviation 88.58
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(Pre-dose)	0.00 μg	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose0-2h)	23.29 μg	Standard Deviation 39.94
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose2-4h)	105.53 μg	Standard Deviation 112.06
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose4-8h)	153.49 μg	Standard Deviation 124.65
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose8-12h)	139.45 μg	Standard Deviation 138.45
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose12-24h)	53.09 μg	Standard Deviation 41.21
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(Pre-dose)	0 μg	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose0-2h)	0.51 μg	Standard Deviation 0.65
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose2-4h)	1.03 μg	Standard Deviation 1.03
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose4-8h)	1.72 μg	Standard Deviation 1.46
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose8-12h)	2.07 μg	Standard Deviation 3.39
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose12-24h)	2.31 μg	Standard Deviation 6.15
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(Pre-dose)	0 μg	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose0-2h)	3.97 μg	Standard Deviation 6.96
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose2-4h)	15.44 μg	Standard Deviation 12.78
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose4-8h)	25.15 μg	Standard Deviation 33.82
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose8-12h)	28.59 μg	Standard Deviation 30
Oxycodone Hydrochloride Single Dose 5 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose12-24h)	26.74 μg	Standard Deviation 30.33
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose4-8h)	68.87 μg	Standard Deviation 131.24
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(Pre-dose)	0.00 μg	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(Pre-dose)	0 μg	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose8-12h)	2.97 μg	Standard Deviation 4.02
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose0-2h)	54.55 μg	Standard Deviation 79.39
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose8-12h)	212.68 μg	Standard Deviation 170.8
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose2-4h)	23.53 μg	Standard Deviation 16.86
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose2-4h)	172.38 μg	Standard Deviation 192.35
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose0-2h)	0.94 μg	Standard Deviation 1.41
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose8-12h)	30.17 μg	Standard Deviation 21.62
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose4-8h)	169.28 μg	Standard Deviation 268.13
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose4-8h)	418.95 μg	Standard Deviation 527.24
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose12-24h)	1.67 μg	Standard Deviation 1.86
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose8-12h)	78.48 μg	Standard Deviation 91.91
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose2-4h)	2.52 μg	Standard Deviation 3.02
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose12-24h)	128.75 μg	Standard Deviation 90.37
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose12-24h)	36.12 μg	Standard Deviation 33.66
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose2-4h)	346.22 μg	Standard Deviation 262.65
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose12-24h)	30.16 μg	Standard Deviation 34.28
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(Pre-dose)	0 μg	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose4-8h)	5.80 μg	Standard Deviation 12.62
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(Pre-dose)	0 μg	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose0-2h)	63.80 μg	Standard Deviation 83.33
Oxycodone Hydrochloride Single Dose 10 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose0-2h)	7.16 μg	Standard Deviation 11.48
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose0-2h)	157.75 μg	Standard Deviation 229.32
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose2-4h)	784.70 μg	Standard Deviation 390.56
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose4-8h)	712.81 μg	Standard Deviation 417.09
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose8-12h)	360.37 μg	Standard Deviation 375.81
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose0-2h)	8.53 μg	Standard Deviation 13.63
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(post dose12-24h)	265.31 μg	Standard Deviation 400.05
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose8-12h)	48.38 μg	Standard Deviation 49.36
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(Pre-dose)	0 μg	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose0-2h)	2.89 μg	Standard Deviation 4.87
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose2-4h)	40.29 μg	Standard Deviation 33.67
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose2-4h)	9.99 μg	Standard Deviation 7.14
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose12-24h)	33.76 μg	Standard Deviation 31.67
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose4-8h)	5.85 μg	Standard Deviation 6.09
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(Pre-dose)	0.00 μg	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose0-2h)	108.57 μg	Standard Deviation 171.53
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose8-12h)	2.49 μg	Standard Deviation 2.62
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose2-4h)	316.07 μg	Standard Deviation 188.88
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(post dose4-8h)	39.64 μg	Standard Deviation 23.9
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose4-8h)	165.45 μg	Standard Deviation 101
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose8-12h)	71.07 μg	Standard Deviation 76.02
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Hydroxymorphine(post dose12-24h)	2.90 μg	Standard Deviation 3.74
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Oxycondone(post dose12-24h)	67.92 μg	Standard Deviation 86.71
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Noroxycodone(Pre-dose)	0 μg	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 20 mg	The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Normethoxymorphone(Pre-dose)	0 μg	Standard Deviation 0

Primary

Tmax,t1/2 for Participants Who Received a Single Dose

To calculate Tmax,t1/2 of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.

Time frame: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

Population: PP popluation

Arm	Measure	Group	Value (MEAN)	Dispersion
Oxycodone Hydrochloride Single Dose 5 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Oxycodone (t1/2)	4.42 hour	Standard Deviation 0.7
Oxycodone Hydrochloride Single Dose 5 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Noroxycodone (t1/2)	6.22 hour	Standard Deviation 1.18
Oxycodone Hydrochloride Single Dose 5 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Normethoxymorphone(Tmax)	1.62 hour	Standard Deviation 1.38
Oxycodone Hydrochloride Single Dose 5 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Normethoxymorphone(t1/2)	7.78 hour	Standard Deviation 1.71
Oxycodone Hydrochloride Single Dose 5 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Hydroxymorphine(Tmax)	0.90 hour	Standard Deviation 0.32
Oxycodone Hydrochloride Single Dose 5 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Noroxycodone (Tmax)	1.32 hour	Standard Deviation 1.36
Oxycodone Hydrochloride Single Dose 5 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Oxycodone (Tmax)	0.98 hour	Standard Deviation 0.43
Oxycodone Hydrochloride Single Dose 10 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Hydroxymorphine (t1/2)	11.70 hour	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 10 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Oxycodone (Tmax)	0.80 hour	Standard Deviation 0.22
Oxycodone Hydrochloride Single Dose 10 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Normethoxymorphone(Tmax)	1.77 hour	Standard Deviation 1.46
Oxycodone Hydrochloride Single Dose 10 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Noroxycodone (Tmax)	1.08 hour	Standard Deviation 0.82
Oxycodone Hydrochloride Single Dose 10 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Normethoxymorphone(t1/2)	9.17 hour	Standard Deviation 1.93
Oxycodone Hydrochloride Single Dose 10 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Noroxycodone (t1/2)	6.63 hour	Standard Deviation 1.47
Oxycodone Hydrochloride Single Dose 10 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Oxycodone (t1/2)	4.38 hour	Standard Deviation 0.57
Oxycodone Hydrochloride Single Dose 10 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Hydroxymorphine(Tmax)	0.87 hour	Standard Deviation 0.33
Oxycodone Hydrochloride Single Dose 20 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Normethoxymorphone(t1/2)	8.22 hour	Standard Deviation 2.28
Oxycodone Hydrochloride Single Dose 20 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Oxycodone (Tmax)	0.73 hour	Standard Deviation 0.18
Oxycodone Hydrochloride Single Dose 20 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Oxycodone (t1/2)	4.24 hour	Standard Deviation 0.52
Oxycodone Hydrochloride Single Dose 20 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Noroxycodone (Tmax)	0.98 hour	Standard Deviation 0.64
Oxycodone Hydrochloride Single Dose 20 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Noroxycodone (t1/2)	6.59 hour	Standard Deviation 0.61
Oxycodone Hydrochloride Single Dose 20 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Hydroxymorphine(Tmax)	1.07 hour	Standard Deviation 0.94
Oxycodone Hydrochloride Single Dose 20 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Hydroxymorphine (t1/2)	7.90 hour	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 20 mg	Tmax,t1/2 for Participants Who Received a Single Dose	Normethoxymorphone(Tmax)	2.04 hour	Standard Deviation 1.84

Primary

Tmax,t1/2 for Participants Who Received Multiple Dose

To calculate Tmax,t1/2 of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.

Time frame: Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.

Population: multiple dose group has 14 subjects

Arm	Measure	Group	Value (MEAN)	Dispersion
Oxycodone Hydrochloride Single Dose 5 mg	Tmax,t1/2 for Participants Who Received Multiple Dose	Oxycodone(t1/2)	5.07 hour	Standard Deviation 1.47
Oxycodone Hydrochloride Single Dose 5 mg	Tmax,t1/2 for Participants Who Received Multiple Dose	Oxycodone( Tmax)	1.35 hour	Standard Deviation 0.65
Oxycodone Hydrochloride Single Dose 5 mg	Tmax,t1/2 for Participants Who Received Multiple Dose	Noroxycodone( Tmax)	1.51 hour	Standard Deviation 1
Oxycodone Hydrochloride Single Dose 5 mg	Tmax,t1/2 for Participants Who Received Multiple Dose	Hydroxymorphine( Tmax)	1.49 hour	Standard Deviation 1
Oxycodone Hydrochloride Single Dose 5 mg	Tmax,t1/2 for Participants Who Received Multiple Dose	Normethoxymorphone( Tmax)	1.86 hour	Standard Deviation 1.48
Oxycodone Hydrochloride Single Dose 5 mg	Tmax,t1/2 for Participants Who Received Multiple Dose	Noroxycodone(t1/2)	7.23 hour	Standard Deviation 1.92
Oxycodone Hydrochloride Single Dose 5 mg	Tmax,t1/2 for Participants Who Received Multiple Dose	Hydroxymorphine(t1/2)	8.09 hour	Standard Deviation 2.6
Oxycodone Hydrochloride Single Dose 5 mg	Tmax,t1/2 for Participants Who Received Multiple Dose	Normethoxymorphone(t1/2)	9.07 hour	Standard Deviation 1.96

Primary

Vd for Participants Who Received a Single Dose

To calculate Apparent Distribution Volume (Vd) Vd of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.

Time frame: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

Population: PP population

Arm	Measure	Group	Value (MEAN)	Dispersion
Oxycodone Hydrochloride Single Dose 5 mg	Vd for Participants Who Received a Single Dose	Oxycodone	568.11 L	Standard Deviation 118.51
Oxycodone Hydrochloride Single Dose 5 mg	Vd for Participants Who Received a Single Dose	Normethoxymorphone	5004.50 L	Standard Deviation 2443.16
Oxycodone Hydrochloride Single Dose 5 mg	Vd for Participants Who Received a Single Dose	Noroxycodone	1119.22 L	Standard Deviation 312.37
Oxycodone Hydrochloride Single Dose 10 mg	Vd for Participants Who Received a Single Dose	Hydroxymorphine	42608.80 L	Standard Deviation 0
Oxycodone Hydrochloride Single Dose 10 mg	Vd for Participants Who Received a Single Dose	Noroxycodone	1026.65 L	Standard Deviation 230.16
Oxycodone Hydrochloride Single Dose 10 mg	Vd for Participants Who Received a Single Dose	Oxycodone	626.45 L	Standard Deviation 115.7
Oxycodone Hydrochloride Single Dose 10 mg	Vd for Participants Who Received a Single Dose	Normethoxymorphone	7297.56 L	Standard Deviation 5341.91
Oxycodone Hydrochloride Single Dose 20 mg	Vd for Participants Who Received a Single Dose	Normethoxymorphone	7460.04 L	Standard Deviation 5956.86
Oxycodone Hydrochloride Single Dose 20 mg	Vd for Participants Who Received a Single Dose	Oxycodone	611.17 L	Standard Deviation 137.94
Oxycodone Hydrochloride Single Dose 20 mg	Vd for Participants Who Received a Single Dose	Noroxycodone	1138.72 L	Standard Deviation 335.51
Oxycodone Hydrochloride Single Dose 20 mg	Vd for Participants Who Received a Single Dose	Hydroxymorphine	52264.20 L	Standard Deviation 0

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

OxyNorm® Capsules (Immediate-Release) Pharmacokinetic (PK) Study

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

AUC0-t and AUC0-∞ for Participants Who Received a Single Dose

AUCss for Participants Who Received Multiple Dose

Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)

Clearance Rate for Participants Who Received a Single Dose

CL for Participants Who Received Multiple Dose

Cmax,Clast for Participants Who Received a Single Dose

Css_min,Css_max and Css_av for Participants Who Received Multiple Dose

Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)

Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)

Fluctuation Index (DF) for Participants Who Received Multiple Dose

ke for Participants Who Received a Single Dose

The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)

The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)

Tmax,t1/2 for Participants Who Received a Single Dose

Tmax,t1/2 for Participants Who Received Multiple Dose

Vd for Participants Who Received a Single Dose