drugset / Trial / NCT04440423

Bioavailability of Clotiazepam 5 mg With Regards to Reference Product

NCT04440423 ↗

Phase 1 Completed 26 enrolled Laboratorios Andromaco S.A.
RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2020-03-11
Primary completion
2020-03-28
Completion
2020-03-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clotiazepam Small molecule 5 mg —

Indications

No indication recorded.