A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2006-09-30

Brief Summary

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This study will determine whether the CT formulation of famotidine taken with and without water is bioequivalent to the FCT formulation. The primary hypothesis is that the area under the concentration-time curve (AUC) and the maximum plasma concentration (Cmax) of a single dose of famotidine 20 mg CT without water are equivalent to a single dose of famotidine 20 mg FCT with water.

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Detailed Description

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Conditions

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Heartburn

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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Sequence 1: FCT with water → CT without water → CT with water

Participants received famotidine 20 mg FCT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 3).

Group Type EXPERIMENTAL

Famotidine FCT

Intervention Type DRUG

Famotidine 20 mg oral film-coated tablet taken once daily

Famotidine CT

Intervention Type DRUG

Famotidine 20 mg oral chewable tablet taken once daily

Sequence 2: CT without water → CT with water → FCT with water

Participants received famotidine 20 mg CT as a single dose without water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 3).

Group Type EXPERIMENTAL

Famotidine FCT

Intervention Type DRUG

Famotidine 20 mg oral film-coated tablet taken once daily

Famotidine CT

Intervention Type DRUG

Famotidine 20 mg oral chewable tablet taken once daily

Sequence 3: CT with water → FCT with water → CT without water

Participants received famotidine 20 mg CT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 3).

Group Type EXPERIMENTAL

Famotidine FCT

Intervention Type DRUG

Famotidine 20 mg oral film-coated tablet taken once daily

Famotidine CT

Intervention Type DRUG

Famotidine 20 mg oral chewable tablet taken once daily

Sequence 4: FCT with water → CT with water → CT without water

Participants received famotidine 20 mg FCT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 3).

Group Type EXPERIMENTAL

Famotidine FCT

Intervention Type DRUG

Famotidine 20 mg oral film-coated tablet taken once daily

Famotidine CT

Intervention Type DRUG

Famotidine 20 mg oral chewable tablet taken once daily

Sequence 5: CT without water → FCT with water → CT with water

Participants received famotidine 20 mg CT as a single dose without water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 3).

Group Type EXPERIMENTAL

Famotidine FCT

Intervention Type DRUG

Famotidine 20 mg oral film-coated tablet taken once daily

Famotidine CT

Intervention Type DRUG

Famotidine 20 mg oral chewable tablet taken once daily

Sequence 6: CT with water → CT without water → FCT with water

Participants received famotidine 20 mg CT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 3).

Group Type EXPERIMENTAL

Famotidine FCT

Intervention Type DRUG

Famotidine 20 mg oral film-coated tablet taken once daily

Famotidine CT

Intervention Type DRUG

Famotidine 20 mg oral chewable tablet taken once daily

Interventions

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Famotidine FCT

Famotidine 20 mg oral film-coated tablet taken once daily

Intervention Type DRUG

Famotidine CT

Famotidine 20 mg oral chewable tablet taken once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female participant is not pregnant or lactating
* Female of childbearing potential must use reliable means of contraception during the course of the study
* Is in good health
* Is able to abstain from smoking during the 24-hour periods before and during each treatment day

Exclusion Criteria

* Has any major systemic disorders
* Has a history of ulcers, other Gastrointestinal (GI) disease, or GI surgery
* Has or has a history of any illness or condition that might interfere with optimal participation in the study
* Has a history of asthma or severe allergies to drugs or foods
* Currently uses prescribed or non-prescribed drugs on a regular basis
* Has a recent history of drug/alcohol abuse
* Consumes more than 6 cups of coffee per day
* Has unconventional or extreme dietary habits
* Has donated blood or has been in a clinical trial in which they received an investigational drug during the past 30 days
* Has a history of allergy or intolerance to antacids
* Is known to be pregnant or is not using reliable means of contraception

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes