Clincosm LogoSign in Get a demo

Bioequivalence Study Of Verapamil

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00668967
Collaborator
(none)
79
Enrollment
1
Location
2
Arms
5
Duration (Months)
15.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
79 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Jul 1, 2008
Actual Study Completion Date :
Jul 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Other: Reference

marketed extended release verapamil tablet

Drug: verapamil
240 mg extended release tablets once daily at bedtime for 28 days
Other Names:
  • Covera HS

    		•
    Other: Test

    reformulated extended release verapamil tablet

    Drug: verapamil
    240 mg extended release tablets once daily at bedtime for 28 days
    Other Names:
  • Covera HS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Primary study endpoints will be AUClast, AUCinf and Cmax of R- and S-verapamil. [5 months]

    Secondary Outcome Measures

    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. [5 months]

    2. Safety and tolerability as assessed by reported adverse events, safety lab test and vital signs [5 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site New Haven Connecticut United States 06511

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00668967
    Other Study ID Numbers:
    • A6661003
    First Posted:
    Apr 29, 2008
    Last Update Posted:
    Jul 8, 2009
    Last Verified:
    Jul 1, 2009
    Keywords provided by , ,
    Cardiovascular Diseases
    Hypertension
    Additional relevant MeSH terms:
    Verapamil

    Study Results

    No Results Posted as of Jul 8, 2009