clinical trial · NCT00830258
Pravastatin Sodium 80 mg Tablets Under Fasting Conditions
Teva Pharmaceuticals USA·phase1·completed·n = 60
HealthyPravastatin sodium 80 mg tabletsPravachol® 80 mg tablets
brief summary
The objective of this study is to evaluate the comparative bioavailability between pravastatin sodium 80 mg tablets (Distributed by Teva Pharmaceuticals, USA) and Pravachol® 80 mg tablets (Bristol Myers Squibb, USA), after a single-dose in healthy subjects under fasting conditions.
started
Apr 1, 2005
primary completion
Apr 1, 2005
completion
Apr 1, 2005
last updated
Aug 19, 2024
detailed description
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Outcome: Confidence interval fell within 80-125% therefore met the FDA Bioequivalence criteria; no drug related, serious, unexpected adverse events were reported during the study.
official title
A Single-Dose, Comparative, Bioavailability Study of Two Formulations of Pravastatin Sodium 80 mg Tablets Under Fasting Conditions
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol