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Fasting Study of Verapamil HCl Extended-Release Capsules 300 mg and Verelan® PM Extended-Release Capsules 300 mg

NCT00647673 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-04-23

No results posted yet for this study

Summary

The objective of this study was to investigate the bioequivalence of Mylan's verapamil HCl extended-release 300 mg capsules to Schwarz's Verelan® PM extended-release 300 mg capsules following evening administration of a single, oral 300 mg (1 x 300 mg) dose under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Verapamil HCL Extended-Release Capsules 300 mg

300mg, single dose fasting

DRUG

Verelan® PM Extended-Release Capsules 300 mg

300mg, single dose fasting

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • James D Carlson, Pharm. D. · PRACS Institute Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2006-01-31
Completion
2006-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00647673 on ClinicalTrials.gov