clinical trial · NCT00835263
Bioequivalence Study of 200 mg Lamotrigine Tablet Under Non-Fasting Conditions
Teva Pharmaceuticals USA·phase1·completed·n = 32
HealthyLamotrigineLamictal®
brief summary
The objective of this study is to compare the rate and extent of absorption of lamotrigine 200 mg tablets (test) versus Lamictal® (reference) administered as 1 x 200 mg tablet under fed conditions.
started
Jan 1, 2002
primary completion
Feb 1, 2002
completion
Feb 1, 2002
last updated
Aug 19, 2024
detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
official title
Randomized, 2-Way, Crossover, Bioequivalence Study of Lamotrigine 200 mg Tablets and Lamictal® 200 mg Tablets Administered as 1 x 200 mg Tablet in Healthy Subjects Under Fed Conditions
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol