To Compare the Safety and Pharmacokinetics of PT105 With PT105R in Healthy Postmenopausal Female Volunteers

A Randomized, Open-label, Single-dosing, 2x2 Crossover Phase 1 Study to Compare the Safety and Pharmacokinetics of PT105 With PT105R in Healthy Postmenopausal Female Volunteers

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04783636

Enrollment

Registered

2021-03-05

Start date

2021-03-11

Completion date

2021-07-20

Last updated

2021-03-17

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

Conditions

Prostate Cancer

Brief summary

The purpose of study is to compare the safety and pharmacokinetics of PT105 with PT105R in healthy postmenopausal female volunteers

Detailed description

The purpose of study is to confirm the safety and pharmacokinetics of PT105 in healthy postmenopausal female volunteers

Interventions

DRUGleuprorelin acetate 3.75mg

PT105, PT105R

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

19 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* A healthy woman who is over 19 years of age and has been certified obstetrically with menopause, at the time of screening. * Subjects weighing over 50 kg with BMI between 18 and 30 kg/m2 (inclusive) at screening visit.

Exclusion criteria

* Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history * Those whose plasma AST and ALT exceed 2 times to the upper limit of the normal range in screening including additional examinations prior to randomization * Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration * Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration

Design outcomes

Primary

Measure	Time frame	Description
AUC7-t of Leuprolide	0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr	AUC7-t
AUCt of Leuprolide	0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr	AUCt
AUCinf of Leuprolide	0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr	AUCinf
Cmax of Leuprolide	0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr	Cmax

Secondary

Measure	Time frame	Description
Tmax of Leuprolide	0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr	Tmax
t1/2 of Leuprolide	0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr	t1/2

Outcome results

None listed

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