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Clinical trial

An Open Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Crossover, Balanced, Single Dose Oral Bioequivalence Study of Lamotrigine Tablets 25 mg (2 × 25 mg Tablets) and 'LAMICTAL®' (Lamotrigine) Tablets 25 mg (2 × 25 mg Tablets) in Healthy Adult Human Subjects Under Fed Conditions.

NCT01618825 is registered in ClinicalTrials.gov with IPCA Laboratories Ltd. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
An Open Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Crossover, Balanced, Single Dose Oral Bioequivalence Study of Lamotrigine Tablets 25 mg (2 × 25 mg Tablets) and 'LAMICTAL®' (Lamotrigine) Tablets 25 mg (2 × 25 mg Tablets) in Healthy Adult Human Subjects Under Fed Conditions.
Lead sponsor
IPCA Laboratories Ltd.
Phase
Phase 1
Overall status
Completed
Start date
March 31, 2012
Completion date
May 31, 2012
Enrollment
28 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

fed