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Tracking Information | |
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First Received Date ICMJE | December 3, 2008 |
Last Updated Date | December 4, 2008 |
Start Date ICMJE | June 2004 |
Current Primary Outcome Measures ICMJE |
Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity. [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00803192 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE | |
Original Secondary Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fed Conditions |
Official Title ICMJE | Randomized, 2-Way Crossover, Bioequivalence Study of Famotidine 40 mg Tablets Administered as 1 x 40 mg Tablet in Healthy Subjects Under Fed Conditions |
Brief Summary | Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40 mg tablet under fed conditions. |
Detailed Description | |
Study Phase | |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Condition ICMJE | Bioavailability |
Intervention ICMJE | Drug: Famotidine Tablets, 40 mg |
Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Completed |
Enrollment ICMJE | 44 |
Completion Date | |
Primary Completion Date | June 2004 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years and older |
Accepts Healthy Volunteers | Yes |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | |
Expanded Access Status | |
Administrative Information | |
NCT ID ICMJE | NCT00803192 |
Responsible Party | Diane Morgan, Perrigo |
Study ID Numbers ICMJE | 40104 |
Study Sponsor ICMJE | Perrigo Company |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Perrigo Company |
Verification Date | December 2008 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |