clinical trial · NCT00849797
Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions
Teva Pharmaceuticals USA·phase1·completed·n = 120
HealthyOxcarbazepineTrileptal®
brief summary
The objective of this study is to compare the rate and extent of absorption of a test formulation of oxcarbazepine tablets and Trileptal® tablets administered as a 1 x 600 mg dose under fed conditions.
started
Jul 1, 2005
primary completion
Jul 1, 2005
completion
Jul 1, 2005
last updated
Aug 19, 2024
detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
official title
Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Oxcarbazepine 600 mg Tablet and Trileptal® Following a 600 mg Dose in Healthy Subjects Under Fed Conditions
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol