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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00647751 |
Purpose
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 fed conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Lamotrigine Tablets 25 mg Drug: Lamictal® Tablets 25 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Single-Dose Food In Vivo Bioequivalence Study of Lamotrigine Tablets (25 mg; Mylan) to Lamictal® Tablets (25 mg; GSK) in Healthy Volunteers |
| Enrollment: | 28 |
| Study Start Date: | August 2004 |
| Study Completion Date: | August 2004 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Lamotrigine Tablets 25 mg
|
Drug: Lamotrigine Tablets 25 mg
2x25mg, single dose fed
|
|
Active Comparator: 2
Lamictal® Tablets 25 mg
|
Drug: Lamictal® Tablets 25 mg
2x25mg, single dose fed
|
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 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:
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: | Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc. |
| ClinicalTrials.gov Identifier: | NCT00647751 History of Changes |
| Other Study ID Numbers: | LAMO-0446 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Lamotrigine Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Cardiovascular Agents Therapeutic Uses Anticonvulsants Central Nervous System Agents |