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

• Status: Not yet recruiting
• Trial end date: 2021-07-20
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Peptron, Inc.
• Treatments: Leuprolide

Criteria

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