A Phase 1 interventional study of Pantoprazole Sodium 40 mg delayed-release tablets and PROTONIX® 40 mg delayed-release tablets. in Healthy, sponsored by Teva Pharmaceuticals USA. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-02-03.
Sponsored by Teva Pharmaceuticals USA (part of Teva Pharmaceutical Industries, Ltd.) · Phase 1 and Interventional
The Objective of this study is to compare the relative bioavailability of pantoprazole sodium 40 mg delayed-released tablets (manufactured by TEVA Pharmaceutical Industries,Ltd. and distributed by TEVA Pharmaceuticals USA)with that of PROTONIX® 40mg delayed-released tablets (Wyeth- Ayerst) in Healthy, adult, non-smoking subjects under non- fasting conditions.
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Teva Pharmaceuticals USA is the lead sponsor of 176 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
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Exclusion Criteria:
Drug: Pantoprazole Sodium 40 mg delayed-release tablets
Drug: PROTONIX® 40 mg delayed-release tablets.
1 x 40 mg
1 x 40 mg
Bioequivalence based on Cmax and AUC
Time frame: 1 month
This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pantoprazole