Study Comparing 2 Different Formulations of Pantoprazole in Healthy Adults.

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NCT00383916

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men or women aged 18 to 50 years.

- Healthy as determined by the investigator.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
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