Overview

Bioavailability of Dienogest 2.0 mg With Regards to Reference Product

Status:
Completed
Trial end date:
2019-12-24
Target enrollment:
Participant gender:
Summary
This Pivotal study will investigate the bioavailability in women of 1 tablet formulations containing Dienogest 2.0 mg. The Pivotal study will be performed at a single site with 30 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 14 days between each study period.
Phase:
Phase 1
Details
Lead Sponsor:
Laboratorios Andromaco S.A.
Treatments:
Dienogest
Nandrolone