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

Randomized, 2-Way Crossover, Bioequivalence Study of Famotidine 40 mg Tablets Administered as 1 x 40 mg Tablet in Healthy Subjects Under Fed Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00803192

Enrollment

Registered

2008-12-05

Start date

2004-06-30

Completion date

Unknown

Last updated

2012-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioavailability

Keywords

bioavailability, famotidine

Brief summary

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

Interventions

DRUGFamotidine Tablets, 40 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026