Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fed Conditions - Tabular View

Tracking Information
First Received Date ^ICMJE	December 3, 2008
Last Updated Date	December 4, 2008
Start Date ^ICMJE	June 2004
Current Primary Outcome Measures ^ICMJE (submitted: December 4, 2008)	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.

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: healthy men or women 18 years of age or older body mass index below 30.0 kg/m2 willing to participate and sin a copy of the informed consent form Exclusion Criteria: recent history of drug or alcohol addiction or abuse pregnant or lactating women history of allergic response to heparin, famotidine, other H2-receptor antagonists, or other related drugs evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant smoking more than 25 cigarettes per day
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