clinical trial · NCT00835588
Pantoprazole Sodium 40 mg DR Tablets Under Fasting Conditions
Teva Pharmaceuticals USA·phase1·completed·n = 100
HealthyPantoprazole Sodium 40 mg delayed-release tabletsPROTONIX® 40 mg delayed-release tablets.
brief summary
The objective of this study is to compare the relative bioavailability of pantoprazole sodium 40 mg delayed-release tablets ( manufactured by TEVA Pharmaceuticals Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PROTONIX® 40 mg delayed-released tablets (Wyeth-Ayerst) in Healthy, adult, non-smoking subjects under fasting conditions.
started
Dec 1, 2003
primary completion
Dec 1, 2003
completion
Dec 1, 2003
last updated
Aug 20, 2024
detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
official title
A Relative Bioavailability Study of Pantoprazole Sodium 40 mg DR Tablets Under Fasting Conditions
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol