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| Sponsored by: |
Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00650364 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan midodrine HCl 5 mg tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fasting 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 Fasting In Vivo Bioequivalence Study of Midodrine HCl Tablets (5 mg; Mylan) and ProAmatine® Tablets (5 mg; Roberts) in Healthy Volunteers |
| Enrollment: | 38 |
| Study Start Date: | August 2002 |
| Study Completion Date: | September 2002 |
| Primary Completion Date: | August 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Midodrine HCl Tablets 5 mg
|
Drug: Midodrine HCl Tablets 5 mg
5mg, single dose fasting
|
|
2: Active Comparator
ProAmatine® Tablets 5 mg
|
Drug: ProAmatine® Tablets 5 mg
5mg, 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.
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 Sullvan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | MIDO-0276 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00650364 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Vasoconstrictor Agents Midodrine |
Cardiovascular Agents Peripheral Nervous System Agents Healthy Adrenergic Agonists |
|
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 Midodrine Vasoconstrictor Agents Peripheral Nervous System Agents |