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