Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets Fasting Study
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
|Official Title:||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.|
- Composite of Pharmacokinetics [ Time Frame: Predose and at 0.50, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.25, 3.50, 3.75, 4.00, 4.25, 4.50, 4.75, 5.00, 5.50, 6.00, 8.00, 10.00, 12.00, 16.00, 20.00 and 24.00 hour post dose in each period ] [ Designated as safety issue: No ]Cmax, Area Under Curve and Tmax
|Study Start Date:||September 2009|
|Study Completion Date:||December 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Experimental: Pantoprazole Sodium Delayed release tablets
Pantoprazole Sodium Delayed release tablets USP 40 mg of OHM Laboratories Inc.,USA
Pantoprazole 40mg Delayed release tablets (Test Product)
Active Comparator: Protonix® Delayed Release 40 mg tablets
Protonix® Delayed Release 40 mg tablets of Wyeth Pharmaceuticals Inc.USA
Protonix® Delayed Release 40 mg tablets (Reference product)
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