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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00649805 |
Purpose
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 by a single, oral 300 mg (1 x 300 mg) dose administration sprinkled on one tablespoon of applesauce 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: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Single-Dose Fasting Bioequivalence Study of Verapamil HCl Extended-Release Capsules (300 mg;Mylan) and Verelan® PM Extended-Release Capsules (300 mg; Schwarz) Sprinkled on Applesauce in Healthy Volunteers |
| Enrollment: | 24 |
| Study Start Date: | January 2006 |
| Study Completion Date: | February 2006 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Verapamil Hydrochloride Extended-Release Capsules, 300 mg
|
Drug: Verapamil Hydrochloride Extended-Release Capsules, 300 mg
300mg, single dose applesauce
|
|
Active Comparator: 2
Verelan® PM extended-release capsules controlled-onset 300 mg
|
Drug: Verelan® PM Extended-Release Capsules, 300 mg
300mg, single dose applesauce
|
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc. |
| ClinicalTrials.gov Identifier: | NCT00649805 History of Changes |
| Other Study ID Numbers: | VERA-05136 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
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 |