NCT00668967

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

July 8, 2009

Status Verified

July 1, 2009

Enrollment Period

5 months

First QC Date

April 25, 2008

Last Update Submit

July 7, 2009

Conditions

Healthy Volunteers

Keywords

Cardiovascular DiseasesHypertension

Outcome Measures

Primary Outcomes (1)

  • Primary study endpoints will be AUClast, AUCinf and Cmax of R- and S-verapamil.

    5 months

Secondary Outcomes (2)

  • 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.

    5 months

  • Safety and tolerability as assessed by reported adverse events, safety lab test and vital signs

    5 months

Study Arms (2)

Reference

OTHER

marketed extended release verapamil tablet

Drug: verapamil

Test

OTHER

reformulated extended release verapamil tablet

Drug: verapamil

Interventions

verapamilDRUG

240 mg extended release tablets once daily at bedtime for 28 days

Also known as: Covera HS
Reference

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female subjects
  • Mass Index (BMI) of approximately 18 to 30 kg/m2

You may not qualify if:

  • Any condition possibly affecting drug absorption
  • A positive urine drug screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesHypertension

Interventions

Verapamil

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 25, 2008

First Posted

April 29, 2008

Study Start

February 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

July 8, 2009

Record last verified: 2009-07

Locations

US(1)