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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00605371 |
This study intends to demonstrate bioequivalence and lack of food effect on 250mg lamotrigine XR in healthy male and female volunteers
Condition | Intervention | Phase |
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Epilepsy Bipolar Disorder |
Drug: Lamotrigine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Bio-equivalence Study |
Official Title: | A Pivotal Single-Dose, Randomised, Parallel-Group, Open-Label Study to Demonstrate Bioequivalence of 250mg Lamotrigine XR Relative to 200mg + 50mg Lamotrigine XR and to Demonstrate Lack of Food Effect on 250mg Lamotrigine XR in Healthy Male and Female Volunteers |
Estimated Enrollment: | 226 |
Study Start Date: | January 2008 |
Study Completion Date: | March 2008 |
Ages Eligible for Study: | 19 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Female subjects of non-child bearing potential will be eligible to participate if they meet the following criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | LEP111102 |
Study First Received: | January 18, 2008 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00605371 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Food and Drug Administration |
Bioequivalence Food Effects Healthy volunteers |
Bipolar Disorder Central Nervous System Diseases Calcium Channel Blockers Healthy Cardiovascular Agents Brain Diseases Calcium, Dietary |
Affective Disorders, Psychotic Epilepsy Mental Disorders Mood Disorders Lamotrigine Psychotic Disorders Anticonvulsants |
Molecular Mechanisms of Pharmacological Action Bipolar Disorder Nervous System Diseases Central Nervous System Diseases Calcium Channel Blockers Cardiovascular Agents Brain Diseases Pharmacologic Actions Membrane Transport Modulators |
Affective Disorders, Psychotic Epilepsy Mental Disorders Therapeutic Uses Mood Disorders Lamotrigine Central Nervous System Agents Anticonvulsants |