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Sponsored by: |
Mylan Pharmaceuticals |
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Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00647608 |
The objective of this study was to investigate the bioequivalence of Mylan's propranolol hydrochloride extended-release 160 mg capsules to Wyeth's Inderal® LA 160 mg capsules following a single, oral 160 mg (1 x 160 mg) dose administered under fed conditions.
Condition | Intervention | Phase |
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Healthy |
Drug: Propranolol Hydrochloride Extended-Release Capsules 160 mg Drug: Inderal® LA Capsules 160 mg |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Single-Dose Fed Bioequivalence Study of Propranolol Hydrochloride Extended-Release Capsules (160 mg; Mylan) and Inderal® LA Capsules (160 mg; Wyeth) in Healthy Volunteers |
Enrollment: | 98 |
Study Start Date: | September 2005 |
Study Completion Date: | October 2005 |
Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Propranolol Hydrochloride Extended-Release Capsules 160 mg
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Drug: Propranolol Hydrochloride Extended-Release Capsules 160 mg
160mg, single dose fed
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2: Active Comparator
Inderal® LA Capsules 160 mg
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Drug: Inderal® LA Capsules 160 mg
160mg, single dose fed
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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 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. |
Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
Study ID Numbers: | PRPL-05116 |
Study First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00647608 History of Changes |
Health Authority: | United States: Institutional Review Board |
Vasodilator Agents Neurotransmitter Agents Adrenergic Agents Propranolol Adrenergic beta-Antagonists |
Adrenergic Antagonists Cardiovascular Agents Anti-Arrhythmia Agents Healthy Antihypertensive Agents |
Neurotransmitter Agents Vasodilator Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents |
Pharmacologic Actions Propranolol Therapeutic Uses Adrenergic beta-Antagonists Adrenergic Antagonists Anti-Arrhythmia Agents |