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

A Single-Dose, Open-Label, Three-Period Crossover Study to Assess the Bioequivalence of Famotidine 20 mg Film-Coated Tablets (FCT) Compared to Famotidine 20 mg Chewable Tablets (CT) Without Water and Famotidine 20 mg Chewable Tablets (CTw) With Water (Protocol 144)

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.

Study Overview

• Status: Completed
• Conditions: Heartburn
• Intervention / Treatment: Drug: Famotidine FCT; Drug: Famotidine CT

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: Famotidine FCT; Famotidine 20 mg oral film-coated tablet taken once daily; Drug: Famotidine CT; Famotidine 20 mg oral chewable tablet taken once daily
Experimental: 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).	Drug: Famotidine FCT; Famotidine 20 mg oral film-coated tablet taken once daily; Drug: Famotidine CT; Famotidine 20 mg oral chewable tablet taken once daily
Experimental: 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).	Drug: Famotidine FCT; Famotidine 20 mg oral film-coated tablet taken once daily; Drug: Famotidine CT; Famotidine 20 mg oral chewable tablet taken once daily
Experimental: 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).	Drug: Famotidine FCT; Famotidine 20 mg oral film-coated tablet taken once daily; Drug: Famotidine CT; Famotidine 20 mg oral chewable tablet taken once daily
Experimental: 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).	Drug: Famotidine FCT; Famotidine 20 mg oral film-coated tablet taken once daily; Drug: Famotidine CT; Famotidine 20 mg oral chewable tablet taken once daily
Experimental: 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).	Drug: Famotidine FCT; Famotidine 20 mg oral film-coated tablet taken once daily; Drug: Famotidine CT; Famotidine 20 mg oral chewable tablet taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water	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.	0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water	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.	0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
Cmax of Famotidine Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water	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.	0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): September 1, 2006
• Study Completion (Actual): September 1, 2006

Study Registration Dates

• First Submitted: July 22, 2009
• First Submitted That Met QC Criteria: July 22, 2009
• First Posted (Estimate): July 24, 2009

Study Record Updates

• Last Update Posted (Actual): March 10, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Heartburn; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Histamine H2 Antagonists; Famotidine
• Other Study ID Numbers: 0208-144; 2009_621 (Other Identifier: Merck Registration Number)

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis