Back to resultsBioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fed Conditions
Primary Purpose
Bioavailability
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Famotidine Tablets, 40 mg
Sponsored by
About this trial
This is an interventional treatment trial for Bioavailability focused on measuring bioavailability, famotidine
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Test Drug
Reference Drug
Arm Description
Outcomes
Primary Outcome Measures
Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00803192
Brief Title
Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fed Conditions
Official Title
Randomized, 2-Way Crossover, Bioequivalence Study of Famotidine 40 mg Tablets Administered as 1 x 40 mg Tablet in Healthy Subjects Under Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Perrigo Company
4. Oversight
5. Study Description
Brief Summary
Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40 mg tablet under fed conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bioavailability
Keywords
bioavailability, famotidine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Drug
Arm Type
Active Comparator
Arm Title
Reference Drug
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Famotidine Tablets, 40 mg
Primary Outcome Measure Information:
Title
Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fed Conditions
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