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

Heartburn Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00945750
• Other study ID #: 0208-144
• Secondary ID: 2009_621
• Status: Completed
• Phase: Phase 1
• First received: July 22, 2009
• Last updated: November 4, 2015
• Start date: August 2006
• Est. completion date: September 2006

Study information

• Verified date: November 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heartburn

Intervention

Drug:
• Famotidine FCT
Famotidine 20 mg oral film-coated tablet taken once daily
• Famotidine CT
Famotidine 20 mg oral chewable tablet taken once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Concentration-time Curve From 0 to Infinity (AUC 0-8) 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	No
Primary	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	No
Secondary	AUC 0-8 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	No
Secondary	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	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site