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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00412191 |
This study intends to demonstrate bioequivalence and lack of food effect on 300mg lamotrigine XR in healthy male and female volunteers
Condition | Intervention | Phase |
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Epilepsy |
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 300mg Lamotrigine XR Relative to 100mg + 200mg Lamotrigine XR and to Demonstrate Lack of Food Effect on 300mg Lamotrigine XR in Healthy Male and Female Volunteers |
Enrollment: | 180 |
Study Start Date: | February 2007 |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | LAM105379 |
Study First Received: | December 14, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00412191 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration |
bioequivalence food effects healthy volunteers |
Calcium, Dietary Epilepsy Lamotrigine Calcium Channel Blockers Central Nervous System Diseases |
Cardiovascular Agents Healthy Brain Diseases Anticonvulsants |
Molecular Mechanisms of Pharmacological Action Nervous System Diseases Central Nervous System Diseases Calcium Channel Blockers Cardiovascular Agents Brain Diseases Pharmacologic Actions |
Membrane Transport Modulators Epilepsy Therapeutic Uses Lamotrigine Central Nervous System Agents Anticonvulsants |