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OpenTrials
Completed

NCT Number: NCT00668967

Bioequivalence Study Of Verapamil

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

Completed

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Key information

Conditions

Healthy Volunteers Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Verapamil

Drug

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

Other names: Covera HS

Primary outcomes

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

    Time frame: 5 months

Secondary outcomes

  1. 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

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

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 29, 2008
Registry last updated
Jul 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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