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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00649688 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan metoprolol tartrate/hydrochlorothiazide 100/50 mg tablets to Novartis Lopressor HCT® 100/50 mg tablets following a single, oral 100/50 mg (1 x 100/50 mg) dose administration under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg Drug: Lopressor HCT® Tablets 100/50 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 Metoprolol Tartrate/Hydrochlorothiazide Tablets (100/50 mg; Mylan) and Lopressor HCT® Tablets (100/50 mg; Novartis) in Healthy Volunteers |
| Enrollment: | 32 |
| Study Start Date: | January 2003 |
| Study Completion Date: | February 2003 |
| Primary Completion Date: | February 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg
|
Drug: Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg
100/50mg, single dose fasting
|
|
2: Active Comparator
Lopressor HCT® Tablets 100/50 mg
|
Drug: Lopressor HCT® Tablets 100/50 mg
100/50mg, single dose fasting
|
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, North Dakota | |
| PRACS Institute, Ltd. | |
| Fargo, North Dakota, United States, 58104 | |
| Principal Investigator: | James D Carlson, Pharm. D. | PRACS Institute Ltd. |
More Information
| Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | METZ-0292 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00649688 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Sympatholytics Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Sodium Chloride Symporter Inhibitors Diuretics Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents Metoprolol Hydrochlorothiazide |
Pharmacologic Actions Membrane Transport Modulators Natriuretic Agents Autonomic Agents Metoprolol succinate Therapeutic Uses Adrenergic beta-Antagonists Adrenergic Antagonists Peripheral Nervous System Agents Anti-Arrhythmia Agents |