Bioequivalence Study Of Verapamil

Verified by: Pfizer, July 2009
First Received: April 25, 2008 | Last Updated: July 7, 2009 | Phase: Phase 1 | Start Date: February 2008
Overall Status: Completed | Estimated Enrollment: 79
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The purpose of this study is to demonstrate bioequivalence of single doses of two verapamil...

Brief Summary

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”

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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • Other: Reference
    • marketed extended release verapamil tablet
  • Other: Test
    • reformulated extended release verapamil tablet

Outcome Measures for this Clinical Trial

Primary Measures

  • Primary study endpoints will be AUClast, AUCinf and Cmax of R- and S-verapamil.
    • Time Frame: 5 months
      Safety Issue?: No

Secondary Measures

  • 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 Issue?: No
  • Safety and tolerability as assessed by reported adverse events, safety lab test and vital signs
    • Time Frame: 5 months
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00668967

Study ID Number: A6661003

ClinicalTrials.gov Identifier: NCT00668967

Health Authority: United States: Food and Drug Administration

To obtain contact information for a study center near you, click here.

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