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

Phase 1 Completed 10 enrolled Laboratorios Andromaco S.A.

RandomizedCrossoverOpen-labelBasic science

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.

Timeline

Start: 2022-03-12
Primary completion: 2022-03-22
Completion: 2022-03-22

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dienogest	Small molecule	2 mg	—
Subject	estradiol valerate	Unknown	2 mg	—

Indications

No indication recorded.