Overview

Bioavailability of Clotiazepam 5 mg With Regards to Reference Product

Status:
Completed
Trial end date:
2020-03-28
Target enrollment:
Participant gender:
Summary
This Pivotal study will investigate the bioavailability in fasting women of 1 Tablet formulations containing Clotiazepam 5 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 7 days between each study period.
Phase:
Phase 1
Details
Lead Sponsor:
Laboratorios Andromaco S.A.