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Sponsored by: |
Torrent Pharmaceuticals Limited |
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Information provided by: | Torrent Pharmaceuticals Limited |
ClinicalTrials.gov Identifier: | NCT00939458 |
Objective:
Study Design:
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Lamotrigine |
Phase I |
Study Type: | Interventional |
Official Title: | A Randomized, Open Label, Single Dose, Crossover, Bioequivalence Study of Lamotrigine 2 x 25 mg IR Tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg Tablets of Glaxo-SmithKline, USA, in Healthy Human Adult Subjects,Under Fed Conditions |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Female Subjects:
Exclusion Criteria:
Study ID Numbers: | 1087/06 |
Study First Received: | July 13, 2009 |
Last Updated: | July 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00939458 History of Changes |
Health Authority: | United States: Institutional Review Board |
Calcium, Dietary Malnutrition Lamotrigine Calcium Channel Blockers |
Cardiovascular Agents Healthy Anticonvulsants |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Therapeutic Uses Lamotrigine Calcium Channel Blockers |
Cardiovascular Agents Central Nervous System Agents Anticonvulsants Pharmacologic Actions |