NCT06834503

Bioequivalence Study of Clonazepam 2 Mg Tablets

Bioequivalence Study of Clonazepam 2 Mg Tablets/immediate Release Tablets in Healthy Subjects in a Fasting Condition

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Centro de Atencion e Investigacion Medica · Network
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Demonstrate the bioequivalence in 1 study, in fasting condition of two formulations of clonazepam 2 mg Tablets / tablets immediate release in order to establish that there are no significant pharmacokinetic differences.

Detailed description

To establish the main pharmacokinetic variables of the two formulations.

Conditions

• Healthy
• Healthy Donors

Interventions

Type	Name	Description
DRUG	Rivotril®	Rivotril® 2 mg
DRUG	Clonazepam TQ 2 mg	Test

Timeline

• Start date: 2025-06-10
• Primary completion: 2025-08-01
• Completion: 2025-11-01
• First posted: 2025-02-19
• Last updated: 2025-03-10