Bioequivalence Study Of Verapamil

Bioequivalence Study Of Verapamil (Covera HS) 240 Mg Extended Release Tablets Produced By Alza Corporation, Vacaville And Pfizer Inc, Puerto Rico: A Two Sequence, Four-Way Crossover Design, Single Dose, Open-Label, Randomized Study In Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00668967

Enrollment

Registered

2008-04-29

Start date

2008-02-29

Completion date

2008-07-31

Last updated

2009-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Cardiovascular Diseases, Hypertension

Brief summary

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

Interventions

DRUGverapamil

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026