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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00648466 |
Purpose
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 administration under fasting 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 Fasting In Vivo Bioequivalence Study of Sumatriptan Succinate Tablets (100 mg; Mylan) to Imitrex® Tablets (100 mg; GlaxoSmithKline) in Healthy Volunteers |
| Enrollment: | 55 |
| Study Start Date: | November 2004 |
| Study Completion Date: | December 2004 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Sumatriptan Succinate Tablets 100 mg
|
Drug: Sumatriptan Succinate Tablets 100 mg
100mg, single dose fasting
|
|
2: Active Comparator
Imitrex® Tablets 100 mg
|
Drug: Imitrex® Tablets 100 mg
100mg, 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/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:
Contacts and Locations| United States, West Virginia | |
| Kendle International Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
| Principal Investigator: | Dorian Williams, M.D. | Kendle International Inc. |
More Information
| Responsible Party: | Mylan Inc. ( Wayne Talton ) |
| Study ID Numbers: | SUMA-0358 |
| Study First Received: | March 30, 2008 |
| Last Updated: | November 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00648466 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Serotonin Agonists Sumatriptan Neurotransmitter Agents Serotonin Agents Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Physiological Effects of Drugs Vasoconstrictor Agents Cardiovascular Agents Pharmacologic Actions |