clinical trial · NCT00850174
Oxcarbazepine 600 mg Tablets Under Fasting Conditions
Teva Pharmaceuticals USA·phase1·completed·n = 60
HealthyOxcarbazepineTrileptal®
brief summary
The objective of this study is to evaluate the comparative bioavailability between Oxcarbazepine 600 mg Tablets (test) and Trileptal® 600 mg Tablets (reference) after a single-dose in healthy subjects under fasting conditions.
started
Apr 1, 2005
primary completion
May 1, 2005
completion
May 1, 2005
last updated
Aug 19, 2024
detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
official title
A Single-Dose, Comparative Bioavailability Study of Two Formulations of Oxcarbazepine 600 mg Tablets Under Fasting Conditions
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol