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

Bioavailability Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803192
• Other study ID #: 40104
• Status: Completed
• Phase: Phase 1
• First received: December 3, 2008
• Last updated: March 15, 2012
• Start date: June 2004

Study information

• Verified date: March 2012
• Source: Perrigo Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40 mg tablet under fed conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. primary completion date: June 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bioavailability

Intervention

Drug:
• Famotidine Tablets, 40 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Perrigo Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity.			No