Overview

Bioavailability of Estradiol Valerate and Dienogest 2 mg/2 mg With Regards to Reference Product

Status:
Completed
Trial end date:
2022-03-22
Target enrollment:
Participant gender:
Summary
This study will investigate the bioavailability in fasting healthy, adult, human post-menopausal female subjects of 1 tablet formulation containing Estradiol Valerate and Dienogest 2 mg/ 2mg. The study will be performed at a single site with 10 subjects. Participants will take 1 tablet of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 7 days between each study period.
Phase:
Phase 1
Details
Lead Sponsor:
Laboratorios Andromaco S.A.
Treatments:
Dienogest
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Nandrolone
Polyestradiol phosphate