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Sponsored by: |
Mylan Pharmaceuticals |
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Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00650416 |
The objective of this study was to investigate the bioequivalence of Mylan's carvedilol 12.5 mg tablets to GSK's Coreg® 12.5 mg tablets following a single, oral 12.5 mg (1 x 12.5 mg) dose administered under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Carvedilol Tablets 12.5 mg Drug: Coreg® Tablets 12.5 mg |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Single-Dose Fasting In Vivo Bioequivalence Study of Carvedilol Tablets (12.5 mg; Mylan) to Coreg® Tablets (12.5 mg; GSK) in Healthy Volunteers |
Enrollment: | 50 |
Study Start Date: | March 2004 |
Study Completion Date: | April 2004 |
Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Carvedilol Tablets 12.5 mg
|
Drug: Carvedilol Tablets 12.5 mg
12.5mg, single dose fasting
|
2: Active Comparator
Coreg® Tablets 12.5 mg
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Drug: Coreg® Tablets 12.5 mg
12.5mg, 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 be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormone replacement therapy are permitted in this study. Acceptable forms of contraception include the following:
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 Carlson, Pharm. D. | PRACS Institute Ltd. |
Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
Study ID Numbers: | CARV-0369 |
Study First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00650416 History of Changes |
Health Authority: | United States: Institutional Review Board |
Vasodilator Agents Neurotransmitter Agents Adrenergic Agents Adrenergic beta-Antagonists Adrenergic Antagonists |
Adrenergic alpha-Antagonists Cardiovascular Agents Healthy Antihypertensive Agents Carvedilol |
Neurotransmitter Agents Vasodilator Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiovascular Agents Adrenergic alpha-Antagonists |
Antihypertensive Agents Pharmacologic Actions Therapeutic Uses Adrenergic beta-Antagonists Adrenergic Antagonists Carvedilol |