NCT00802828

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2008

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

Enrollment Period

Same day

First QC Date

December 3, 2008

Last Update Submit

March 15, 2012

Conditions

Bioavailability

Keywords

bioavailabilityfamotidine

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity

Study Arms (2)

Test Product

ACTIVE COMPARATOR
Drug: Famotidine Tablets, 40 mg

Reference Product

ACTIVE COMPARATOR
Drug: Famotidine Tablets, 40 mg

Interventions

Famotidine Tablets, 40 mgDRUG
Reference ProductTest Product

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • recipient of any drugs as part of a research study within 30 days prior to study dosing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Famotidine

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2008

First Posted

December 5, 2008

Study Start

June 1, 2004

Primary Completion

June 1, 2004

Last Updated

March 16, 2012

Record last verified: 2012-03