Study Comparing 2 Different Formulations of Pantoprazole in Healthy Adults.
NCT00383916
Last updated date
ABOUT THIS STUDY
A study comparing 2 different investigational formulations of pantoprazole in healthy adults.
FOR MORE INFORMATION
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Eligibility Criteria
condition
Healthy Subjects
Sex
Females and Males
Age
18-50 years
Inclusion Criteria
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- Men or women aged 18 to 50 years.
- Healthy as determined by the investigator.
Exclusion Criteria
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- History or active presence of clinically important medical disease.
- History of drug or alcohol abuse.
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Comparing 2 Different Formulations of Pantoprazole in Healthy Adults. | |||
Official Title ICMJE | 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. | |||
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 Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Healthy Subjects | |||
Intervention ICMJE | Drug: pantoprazole | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | Not Provided | |||
Original Enrollment ICMJE | Not Provided | |||
Study Completion Date ICMJE | October 2006 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00383916 | |||
Other Study ID Numbers ICMJE | 3001B1-119 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | March 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |