NCT00383916CompletedPhase 1
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.
Wyeth is now a wholly owned subsidiary of Pfizer0 sitesStarted: October 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Primary Endpoint
- To determine the bioequivalence of the Altana formulation of pantoprazole to the Wyeth formulation of pantoprazole delayed-release granules.
Study Overview
Brief Summary
A study comparing 2 different investigational formulations of pantoprazole in healthy adults.
Detailed Description
open-label, single-dose, randomized, 2-period, 2-sequence, crossover, inpatient bioequivalence study
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Men or women aged 18 to 50 years.
- •Healthy as determined by the investigator.
Exclusion Criteria
- •History or active presence of clinically important medical disease.
- •History of drug or alcohol abuse.
Outcomes
Primary Outcomes
To determine the bioequivalence of the Altana formulation of pantoprazole to the Wyeth formulation of pantoprazole delayed-release granules.
Secondary Outcomes
- To obtain additional safety and tolerability data concerning pantoprazole in healthy subjects and to assess the pharmacokinetics of the Altana formulation.
Investigators
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