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Sponsored by: |
Mylan Pharmaceuticals |
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Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00650013 |
The objective of this study was to investigate the bioequivalence of Mylan's midodrine HCl 5 mg tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fed conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Midodrine HCl Tablets 5 mg Drug: ProAmatine® Tablets 5 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 Midodrine HCl Tablets (5 mg; Mylan) and ProAmatine® Tablets (5 mg; Roberts) in Healthy Volunteers |
Enrollment: | 23 |
Study Start Date: | July 2002 |
Study Completion Date: | August 2002 |
Primary Completion Date: | August 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Midodrine HCl Tablets 5 mg
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Drug: Midodrine HCl Tablets 5 mg
5mg, single dose fed
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2: Active Comparator
ProAmatine® Tablets 5 mg
|
Drug: ProAmatine® Tablets 5 mg
5mg, single dose fed
|
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. Acceptable forms of contraception include the following:
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
United States, West Virginia | |
Kendle International Inc. | |
Morgantown, West Virginia, United States, 26505 |
Principal Investigator: | Thomas S Clark, M.D. | Kendle International Inc. |
Responsible Party: | Mylan Inc. ( Will Sullivan, Global Head of Product Risk and Safety Management ) |
Study ID Numbers: | MIDO-0277 |
Study First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00650013 |
Health Authority: | United States: Institutional Review Board |
Midodrine Healthy |
Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Sympathomimetics Physiological Effects of Drugs Cardiovascular Agents |
Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Vasoconstrictor Agents Peripheral Nervous System Agents |