Bioequivalence Study of Torrent Pharmaceutical Limited's Pantoprazole Sodium 40 mg Delayed Release Tablets Under Fed Conditions
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|ClinicalTrials.gov Identifier: NCT01418443|
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : August 17, 2011
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
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Torrent's Pantoprazole Sodium Delayed - Release Tablets||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|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 Fed Conditions|
- bioequivalence based on Composite of Pharmacokineticsbioequivalence; 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, AUCo-t and Cmax.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418443
|Lotus Labs Pvt. Ltd.|
|Bangalore,, Karnataka,, India|