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| Sponsored by: |
Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00648271 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan's metoprolol tartrate tablets to Novartis' Lopressor® tablets following a single, oral 50 mg (2 x 25 mg tablets for Mylan's formulation and 1 x 50 mg for Lopressor®) dose administered under fed conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Metoprolol Tartrate Tablets 25 mg Drug: Lopressor® Tablets 50 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| Official Title: | Single-Dose Food In Vivo Bioequivalence Study of Metoprolol Tartrate Tablets (25 mg; Mylan) and Lopressor® (50 mg; Novartis) in Healthy Volunteers |
| Enrollment: | 19 |
| Study Start Date: | December 2002 |
| Study Completion Date: | January 2003 |
| Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Metoprolol Tartrate Tablets 25 mg
|
Drug: Metoprolol Tartrate Tablets 25 mg
2x50mg, single dose fed
|
|
2: Active Comparator
Lopressor® Tablets 50 mg
|
Drug: Lopressor® Tablets 50 mg
1x50mg, single dose fed
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and 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 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:
Contacts and Locations| United States, West Virginia | |
| Kendle International Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
| Principal Investigator: | Thomas S Clark, M.D. | Kendle International Inc. |
More Information
| Responsible Party: | Mylan Inc. ( Will Sullivan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | METP-02138 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00648271 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Neurotransmitter Agents Adrenergic Agents Metoprolol succinate Adrenergic beta-Antagonists Adrenergic Antagonists Peripheral Nervous System Agents |
Cardiovascular Agents Anti-Arrhythmia Agents Healthy Antihypertensive Agents Metoprolol |
|
Sympatholytics Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiovascular Agents Metoprolol Antihypertensive Agents |
Pharmacologic Actions Autonomic Agents Metoprolol succinate Therapeutic Uses Adrenergic beta-Antagonists Adrenergic Antagonists Peripheral Nervous System Agents Anti-Arrhythmia Agents |