Study Comparing 2 Different Formulations of Pantoprazole in Healthy Adults.
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Subjects
Intervention: pantoprazole (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Summary
A study comparing 2 different investigational formulations of pantoprazole in healthy
adults.
Clinical Details
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 design: Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Bio-equivalence Study
Primary outcome: To determine the bioequivalence of the Altana formulation of pantoprazole to the Wyeth formulation of pantoprazole delayed-release granules.
Secondary outcome: To obtain additional safety and tolerability data concerning pantoprazole in healthy subjects and to assess the pharmacokinetics of the Altana formulation.
Detailed description:
open-label, single-dose, randomized, 2-period, 2-sequence, crossover, inpatient
bioequivalence study
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: October 2006
Ending date: October 2006
Last updated: March 7, 2007
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