A Phase 1 interventional study of Lamotrigine and Lamictal® in Healthy, sponsored by Dr. Reddy's Laboratories Limited. Completed at 1 site in United States. Open to participants aged 20 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-01-20.
Sponsored by Dr. Reddy's Laboratories Limited · Phase 1, Interventional, and Treatment
This is an single dose,two-way, crossover, oral bioequivalence study.
The study was an single dose, two-way crossover, oral bioequivalence study of Lamotrigine tablets 200 mg of Dr. Reddy's Laboratories Limited, India comparing with that of LAMICTAL® tablets 200 mg of GlaxoSmithKline Inc, in healthy, adult, human subjects under fasting condition. 26 subjects (19 men and 7 womens) are enrolled and completed the study. The washout period is 14 days between the two periods of the study.
Dr. Reddy's Laboratories Limited is the lead sponsor of 220 studies on the registry; 2 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Lamotrigine Tablets 200 mg of Dr. Reddy's Laboratories Limited
Drug: Lamotrigine · Drug: Lamictal®
Lamictal® 200 mg Tablets of GlaxoSmithKline Inc
Drug: Lamotrigine · Drug: Lamictal®
Lamotrigine Tablets 200 mg
Also known as: Lamictal® 200 mg
Lamictal® 200 mg Tablets
Area under curve (AUC)
Time frame: Pre-dose 0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,36,48,72,96,120 hours
This study is completed, as verified in Oct 2002. You cannot join it, but the record below documents what was studied.
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Dr. Reddy's Laboratories Limited