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

Phase 1

Completed

• Conditions: Heartburn
• Interventions: Drug: Famotidine FCT; Drug: Famotidine CT

• Registration Number: NCT00945750
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-24
• Results First Submitted: 2015-08-17
• Results First Submitted QC: 2015-11-04
• Results First Posted: 2015-12-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2: CT without water → CT with water → FCT with water	Famotidine CT	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).
Sequence 6: CT with water → CT without water → FCT with water	Famotidine CT	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).
Sequence 1: FCT with water → CT without water → CT with water	Famotidine FCT	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).
Sequence 2: CT without water → CT with water → FCT with water	Famotidine FCT	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).
Sequence 1: FCT with water → CT without water → CT with water	Famotidine CT	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).
Sequence 4: FCT with water → CT with water → CT without water	Famotidine CT	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).
Sequence 5: CT without water → FCT with water → CT with water	Famotidine CT	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).
Sequence 3: CT with water → FCT with water → CT without water	Famotidine FCT	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).
Sequence 4: FCT with water → CT with water → CT without water	Famotidine FCT	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).
Sequence 5: CT without water → FCT with water → CT with water	Famotidine FCT	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).
Sequence 6: CT with water → CT without water → FCT with water	Famotidine FCT	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).
Sequence 3: CT with water → FCT with water → CT without water	Famotidine CT	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).

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve From 0 to Infinity (AUC 0-∞) Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water	0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose	AUC values were natural log-transformed and analyzed using an analysis of variance (ANOVA) model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.
Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water	0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose	Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.

Secondary Outcome Measures

Name	Time	Method
AUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water	0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose	AUC values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.
Cmax of Famotidine Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water	0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose	Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.