Bioequivalence Study Of Verapamil - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00668967

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 I

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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Verapamil Diltiazem hydrochloride Dexverapamil Diltiazem Diltiazem malate Verapamil hydrochloride

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

Criteria

Inclusion Criteria:

Exclusion Criteria:

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:

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 February 09, 2012