Bioequivalence Study Of Verapamil

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: verapamil

• Registration Number: NCT00668967
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to demonstrate bioequivalence of single doses of two verapamil formulations

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-04-25
• Study First Submitted QC: 2008-04-25
• Study First Posted: 2008-04-29
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-07
• Last Update Posted: 2009-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• Healthy male and/or female subjects
• Mass Index (BMI) of approximately 18 to 30 kg/m2

Exclusion Criteria

• Any condition possibly affecting drug absorption
• A positive urine drug screen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference	verapamil	marketed extended release verapamil tablet
Test	verapamil	reformulated extended release verapamil tablet

Primary Outcome Measures

Name	Time	Method
Primary study endpoints will be AUClast, AUCinf and Cmax of R- and S-verapamil.	5 months

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints will include Tmax and t1/2 of R- and S-verapamil and S- and R- norverapamil, as data permit. AUClast, AUCinf and Cmax of R- and S-norverapamil as data permit.	5 months
Safety and tolerability as assessed by reported adverse events, safety lab test and vital signs	5 months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States