Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Mylan Pharmaceuticals |
---|---|
Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00648050 |
The objective for 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 administration under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Verapamil Hydrochloride Extended-Release Capsules, 300 mg Drug: Verelan® PM Extended-Release Capsules, 300 mg |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Single-Dose Fasting Bioequivalence Study of Verapamil HCl Extended-Release Capsules (300 mg; Mylan) to Verelan® PM Extended-Release Capsules (300 mg; Schwarz) in Healthy Volunteers Dosed in the Evening |
Enrollment: | 72 |
Study Start Date: | March 2006 |
Study Completion Date: | March 2006 |
Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Verapamil Hydrochloride Extended-Release Capsules, 300 mg
|
Drug: Verapamil Hydrochloride Extended-Release Capsules, 300 mg
300mg, single dose fasting
|
2: Active Comparator
Verelan® PM Extended-Release Capsules, 300 mg
|
Drug: Verelan® PM Extended-Release Capsules, 300 mg
300mg, single dose fasting
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and/or non-pregnant, non-lactating female.
Women of childbearing potential must practice abstinence or use an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormonal replacement therapies are permitted in this study. Acceptable forms of contraception include the following:
Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
United States, North Dakota | |
PRACS Institute, Ltd. | |
Fargo, North Dakota, United States, 58104 |
Principal Investigator: | James D Carlson, Pharm. D. | PRACS Institute Ltd. - Cetero Research |
Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
Study ID Numbers: | VERA-0613 |
Study First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00648050 |
Health Authority: | United States: Institutional Review Board |
Calcium, Dietary Verapamil Diltiazem Healthy |
Membrane Transport Modulators Vasodilator Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Calcium Channel Blockers |
Cardiovascular Agents Anti-Arrhythmia Agents Antihypertensive Agents Pharmacologic Actions |