Bioequivalence Study Of Verapamil

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00668967
First received: April 25, 2008
Last updated: July 7, 2009
Last verified: July 2009
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
Drug: verapamil
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Primary study endpoints will be AUClast, AUCinf and Cmax of R- and S-verapamil. [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
  • Safety and tolerability as assessed by reported adverse events, safety lab test and vital signs [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Enrollment: 79
Study Start Date: February 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Reference
marketed extended release verapamil tablet
Drug: verapamil
240 mg extended release tablets once daily at bedtime for 28 days
Other Name: Covera HS
Test
reformulated extended release verapamil tablet
Drug: verapamil
240 mg extended release tablets once daily at bedtime for 28 days
Other Name: Covera HS

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668967

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00668967     History of Changes
Other Study ID Numbers: A6661003
Study First Received: April 25, 2008
Last Updated: July 7, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Cardiovascular Diseases
Hypertension

Additional relevant MeSH terms:
Verapamil
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on September 18, 2014