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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test Product

Group Type ACTIVE_COMPARATOR

Famotidine Tablets, 40 mg

Intervention Type DRUG

Reference Product

Group Type ACTIVE_COMPARATOR

Famotidine Tablets, 40 mg

Intervention Type DRUG

Interventions

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Famotidine Tablets, 40 mg

Intervention Type DRUG

Eligibility Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes