drugset / Trial / NCT04440423
Bioavailability of Clotiazepam 5 mg With Regards to Reference Product
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Clotiazepam | Small molecule | 5 mg | — |
Indications
No indication recorded.