Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-09 @ 11:17 PM
Study NCT ID:
NCT01654705
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2012-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets Fasting Study
Sponsor:
Ranbaxy Laboratories Limited
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: