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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00383916 |
A study comparing 2 different investigational formulations of pantoprazole in healthy adults.
Condition | Intervention | Phase |
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Healthy Subjects |
Drug: pantoprazole |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Bio-equivalence Study |
Official Title: | An Open-Label, Single-Dose, Randomized, 2-Period, Crossover, Bioequivalence Study Between the Altana Formulation of Pantoprazole Delayed-Release Granules and the Wyeth Formulation of Pantoprazole Delayed-Release Granules in Healthy Subjects. |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2006 |
open-label, single-dose, randomized, 2-period, 2-sequence, crossover, inpatient bioequivalence study
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion Criteria
Study ID Numbers: | 3001B1-119 |
Study First Received: | October 2, 2006 |
Last Updated: | March 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00383916 History of Changes |
Health Authority: | United States: Food and Drug Administration |
healthy |
Pantoprazole Healthy |
Therapeutic Uses Pantoprazole Anti-Ulcer Agents Gastrointestinal Agents Pharmacologic Actions |