clinical trial · NCT00838279
Lamotrigine 25 mg Chewable Tablets, Fasting
Teva Pharmaceuticals USA·phase1·completed·n = 32
HealthyLamotrigine 25 mg Chewable TabletsLamictal® 25 mg Chewable Tablets
brief summary
The objective of this study is to compare the rate and extent of absorption of lamotrigine 25 mg chewable dispersible tablets (test) versus Lamictal® (reference) administered as 2 x 25 mg chewable dispersible tablets under fasting conditions.
started
Feb 1, 2002
primary completion
Mar 1, 2002
completion
Mar 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 25 mg Chewable Dispersible Tablets and Lamictal® 25 mg Chewable Dispersible Tablets in Healthy Subjects Under Fasting Conditions
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol