Pantoprazole Sodium 40 mg DR Tablets Under Fasting Conditions

Phase 1 Completed 100 enrolled Teva Pharmaceuticals USA

RandomizedCrossoverOpen-labelOther

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.

Timeline

Start: 2003-12
Primary completion: 2003-12
Completion: 2003-12

Outcome

Met primary endpoint

registry analysis (unspecified test); Pantoprazole vs Protonix®; Geometric Test/Ref Ratio x 100 88.8 (90% CI 82.7 to 95.4) NCT00835588 ↗

registry analysis (unspecified test); Pantoprazole vs Protonix®; Geometric Test/Ref Ratio x 100 97.3 (90% CI 93.4 to 101) NCT00835588 ↗

registry analysis (unspecified test); Pantoprazole vs Protonix®; Geometric Test/Ref Ratio x 100 95.6 (90% CI 91.6 to 99.8) NCT00835588 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pantoprazole	Other / unclassified	40 mg	—

Indications

No indication recorded.