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Sponsored by: |
Mylan Pharmaceuticals |
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Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00650208 |
The objective of this study was to investigate the bioequivalence of Mylan's lamotrigine 25 mg tablets to GlaxoSmithKline's (GSK) Lamictal® 25 mg tablets following a single, oral 50 mg (2 x 25 mg) dose administration under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Lamotrigine Tablets 25 mg Drug: Lamictal® Tablets 25 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 Lamotrigine Tablets (25 mg; Mylan) to Lamictal® Tablets (25 mg; GSK) in Healthy Volunteers |
Enrollment: | 27 |
Study Start Date: | July 2004 |
Study Completion Date: | August 2004 |
Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Lamotrigine Tablets 25 mg
|
Drug: Lamotrigine Tablets 25 mg
2x25mg, single dose fasting
|
2: Active Comparator
Lamictal® Tablets 25 mg
|
Drug: Lamictal® Tablets 25 mg
2x25mg, single dose fasting
|
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 must practice abstinence or be using an acceptable form of contraception throughout the study. No hormonal contraceptives or hormonal replacement therapies are permitted in this study. Acceptable forms of contraception include the following:
Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
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: | LAMO-0445 |
Study First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00650208 |
Health Authority: | United States: Institutional Review Board |
Calcium, Dietary Lamotrigine Healthy |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Therapeutic Uses Calcium Channel Blockers |
Cardiovascular Agents Central Nervous System Agents Anticonvulsants Pharmacologic Actions |