Text Size

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
History of Changes
  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:

U.S. FDA Resources

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
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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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
Diltiazem
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents

ClinicalTrials.gov processed this record on June 18, 2013