clinical trial · NCT00834522
Granisetron 1 mg Tablets, Non-fasting
Teva Pharmaceuticals USA·phase1·completed·n = 80
HealthyGranisetron hydrochloride 1 mg tabletsKytril® 1 mg tablets
brief summary
The objective of this study is to evaluate the comparative bioavailability between granisetron hydrochloride 1 mg tablets (Teva Pharmaceuticals USA) and Kytril® 1 mg tablets (Roche, USA), after a single-dose in health subjects 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
A Single-Dose, Comparative Bioavailability Study of Two Formulations of Granisetron 1 mg Tablets Under Fed Conditions
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol