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Sponsored by: |
Mylan Pharmaceuticals |
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Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00650247 |
The objective of this study was to investigate the bioequivalence of Mylan's sumatriptan succinate 100 mg tablets to GSK's Imitrex® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administered under fed conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Sumatriptan Succinate Tablets 100 mg Drug: Imitrex® Tablets 100 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 Sumatriptan Succinate Tablets (100 mg; Mylan) to Imitrex® Tablets (100 mg; GlaxoSmithKline) in Healthy Volunteers |
Enrollment: | 57 |
Study Start Date: | November 2004 |
Study Completion Date: | December 2004 |
Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Sumatriptan Succinate Tablets 100 mg
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Drug: Sumatriptan Succinate Tablets 100 mg
100mg, single dose fed
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2: Active Comparator
Imitrex® Tablets 100 mg
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Drug: Imitrex® Tablets 100 mg
100mg, 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/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 hormone 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:
United States, West Virginia | |
Kendle International Inc. | |
Morgantown, West Virginia, United States, 26505 |
Principal Investigator: | Dorian Williams, M.D. | Kendle International Inc. |
Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
Study ID Numbers: | SUMA-0359 |
Study First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00650247 |
Health Authority: | United States: Institutional Review Board |
Sumatriptan Healthy Serotonin |
Serotonin Agonists Neurotransmitter Agents Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Physiological Effects of Drugs Vasoconstrictor Agents Cardiovascular Agents Pharmacologic Actions |