Bioequivalence Study Of Verapamil

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: verapamil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00668967

A6661003

Details and patient eligibility

About

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

Enrollment: 79 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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79 participants in 2 patient groups

Reference

Other group

Description:

marketed extended release verapamil tablet

Treatment:

Drug: verapamil

Drug: verapamil

Test

Other group

Description:

reformulated extended release verapamil tablet

Treatment:

Drug: verapamil

Drug: verapamil