clinical trial · NCT00834561
Bioequivalence Study of 200 mg Lamotrigine Tablet Under Fasting Conditions
Teva Pharmaceuticals USA·phase1·completed·n = 32
HealthyLamotrigineLamictal®
brief summary
This is a bioequivalence study to compare the rate and extent of absorption of lamotrigine (test) and Lamictal® (reference)administered as a 1 x 200 mg tablet under fasting 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, Two-Way Crossover, Single-Dose, Fasting Bioequivalence Study of Lamotrigine 1 x 200 mg Tablet
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol