NCT04440423

Bioavailability of Clotiazepam 5 mg With Regards to Reference Product

Bioavailability of a Formulation of Clotiazepam 5 mg Coated Tablets With Regards to the Marketed Reference Product

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Laboratorios Andromaco S.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The primary objective of the study is to investigate the relative bioavailability of Clotiazepam of 1 tablet formulation with Clotiazepam 5 mg and to demonstrate bioequivalence of both formulations in terms of rate and extent of absorption: * Test Product: Product manufactured by Tecnandina S.A., Ecuador. * Reference Product: Rize \[Trademark\], product of Mitsubishi Tanabe Pharma, Japan. The 90% confidence intervals for the intra-subject coefficient of variation (Test versus Reference Product) for the main pharmacokinetic parameters área under the plasma concentration-time curve from time zero to time t (AUC0-t) and from time zero to 72 hours (AUC0-72), and maximum plasma concentration (Cmax) for total Levonorgestrel and Ethinyl estradiol will be determined. Participants will be confined in the study site for approximately 36 hours during each study period (for 12 hours pre-dosing and for 12 hours post dosing) during which pharmacokinetic (PK) blood samples will be obtained. 18 blood samples will be taken up to 24 hours after the administration in each period. Participants will return to the site to provide additional blood samples at 24 h and 34 h postdose. The washout period between the two study periods will be at least 7 days. The samples from each participant will be analyzed with 2 methods of highperformance liquid chromatography-tandem mass spectrometry bioanalytical assays to quantify total Levonorgestrel and Ethinyl estradiol in plasma. The safety objective is to evaluate the tolerability of both formulations in women by collecting adverse events.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Clotiazepam 5 mg Test Product Coated Tablets	Investigational Medicinal Product
DRUG	Clotiazepam 5 mg Reference Product Coated Tablets	Rize (Trademark)

Timeline

• Start date: 2020-03-11
• Primary completion: 2020-03-28
• Completion: 2020-03-28
• First posted: 2020-06-19
• Last updated: 2020-06-19

Locations

1 site across 1 country: Chile