NCT01654705

Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets Fasting Study

An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover Bioequivalence Study Comparing Pantoprazole Sodium 40 mg Delayed Release Tablets (Containing 45.1 mg of Pantoprazole Sodium Sesquihydrate Equivalent to 40 mg of Pantoprazole) of Ohm Laboratories Inc. (a Subsidiary of Ranbaxy Pharmaceuticals Inc, USA) With PROTONIX® 40 mg Delayed Release Tablets (Containing 45.1 mg of Pantoprazole Sodium Sesquihydrate Equivalent to 40 mg of Pantoprazole) of Wyeth Pharmaceuticals Inc. in Healthy, Adult, Male, Human Subjects Under Fasting Conditions.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 19 Years – 43 Years
• Healthy volunteers: Accepted

Summary

This study was to compare the single-dose oral bioequivalence of Pantoprazole sodium 40 mg delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate equivalent to 40 mg of Pantoprazole) of OHM Laboratories Inc. USA (a subsidiary of Ranbaxy Pharmaceuticals Inc. USA) with PROTONIX® 40 mg delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate equivalent to 40 mg of Pantoprazole) of Wyeth Pharmaceuticals Inc., USA in healthy, adult, human, male subjects under fasting conditions.condition.

Detailed description

The study was an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence under fasting condition. A washout period of 04 days was enforced between the administrations of study drugs in each period.. At study check-in, the subjects reported to the clinical site at least 36 hours prior to Day 1 dosing and were required to stay for 24 hours after Day 1 dosing. Blood sample collections were obtained within 90 minutes prior to dosing (0 hour) and after dose administration at periodic interval up to 24.00 hour in each period. A total number of blood draws during the study were fifty-four (54) and the total volume of blood drawn did not exceed 274 mL. Following an overnight fast of at least 10 hour, a single oral dose of Pantoprazole sodium delayed release tablets 40 mg of either test or reference drug product was administered during each period of the study, along with 240 mL of drinking water at ambient temperature under low light condition and under supervision of trained study personnel. Both test and reference drug products were administered to all the study subjects one in each period

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pantoprazole	Pantoprazole 40mg Delayed release tablets (Test Product)
DRUG	Pantoprazole	Protonix® Delayed Release 40 mg tablets (Reference product)

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-09-01
• Completion: 2009-12-01
• First posted: 2012-08-01
• Last updated: 2012-08-01

Locations

1 site across 1 country: India