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: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

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

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

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

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

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

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