Bioequivalence Study of Torrent Pharmaceutical Limited's Pantoprazole Sodium 40 mg Delayed Release Tablets Under Fasting Conditions
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.
randomized, open label, two treatment, two period, two sequence, single dose, crossover study in healthy human adult subjects
Drug: Torrent's Pantoprazole Sodium Delayed - Release Tablets
|Official Title:||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 Fasting Conditions|
- Bioequivalence based on Cmax parameter [ Designated as safety issue: No ]bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for Cmax
- Bioequivalence based AUC parameterbioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUC(o-t).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418417
|Lotus Labs Pvt. Ltd.|
|Bangalore,, Karnataka,, India|