NCT01418443

Bioequivalence Study of Torrent Pharmaceutical Limited's Pantoprazole Sodium 40 mg Delayed Release Tablets Under Fed Conditions

A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets of Torrent Pharmaceutical Limited., India and Protonix® (Pantoprazole Sodium) 40 mg Delayed Release Tablets of Wyeth Pharmaceuticals Inc, in Healthy Human Adult Subjects, Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Torrent Pharmaceuticals Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Objective: To compare the single dose bioavailability of Torrent's Pantoprazole Sodium Delayed - Release Tablets 1 × 40 mg and PROTONIX® (Pantoprazole Sodium) Delayed - Release Tablets 1 × 40 mg of Wyeth Pharmaceutical Inc. Dosing periods were separated by a washout period of at least 7 days. Study Design: randomized, open label, two treatment, two period, two sequence, single dose, crossover study in healthy human adult subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Torrent's Pantoprazole Sodium Delayed - Release Tablets

Timeline

• First posted: 2011-08-17
• Last updated: 2011-08-17

Locations

1 site across 1 country: India