Bioequivalence Study Of Verapamil

Phase 1CompletedNCT00668967

Pfizer79 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

verapamilDRUG

240 mg extended release tablets once daily at bedtime for 28 days

verapamilDRUG

240 mg extended release tablets once daily at bedtime for 28 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Primary study endpoints will be AUClast, AUCinf and Cmax of R- and S-verapamil.

Time frame: 5 months

Secondary Outcomes

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.

Time frame: 5 months

Safety and tolerability as assessed by reported adverse events, safety lab test and vital signs

Time frame: 5 months

Data from ClinicalTrials.gov

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