DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heartburn

Intervention: famotidine film-coated tablet (FCT) (Drug); Comparator: famotidine chewable tablet (CT) (Drug); Comparator: famotidine chewable tablet (CT) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

This study will determine whether the chewable tablet (CT) formulation of famotidine taken with and without water is bioequivalent to the film coated tablet (FCT) formulation.

Clinical Details

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

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

Primary outcome:

Area under the curve (AUC(0 to infinity)) following single dose administration of famotidine CT without water and famotidine FCT with water

Peak plasma concentration (Cmax) of famotidine following single dose administration of famotidine CT without water and famotidine FCT with water

Secondary outcome:

Area under the curve (AUC(0 to infinity)) following single dose administration of famotidine CT with water and famotidine FCT with water

Peak plasma concentration (Cmax) of famotidine following single dose administration of famotidine CT with water and famotidine FCT with water

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Female subject is not pregnant or lactating

- Females of childbearing potential must use reliable means of contraception during the

course of the study

- Subject is in good health

- Subject is able to abstain from smoking during the 24-hour periods before and during

each treatment day Exclusion Criteria:

- Subject has any major systemic disorders

- Subject has a history of ulcers, other GI disease, or GI surgery

- Subject has or has a history of any illness or condition that might interfere with

optimal participation in the study

- Subject has a history of asthma or severe allergies to drugs or foods

- Subject currently uses prescribed or nonprescribed drugs on a regular basis

- Subject has a recent history of drug/alcohol abuse

- Subject consumes more than 6 cups of coffee per day

- Subject has unconventional or extreme dietary habits

- Subject has donated blood or has been in a clinical trial in which they received an

investigational drug during the past 30 days

- Subject has a history of allergy or intolerance to antacids

- Female subject is known to be pregnant or is not using reliable means of

contraception

Locations and Contacts

Additional Information

MedWatch - FDA maintained medical product safety Information

Merck: Patient & Caregiver U.S. Product Web Site

Starting date: August 2006
Last updated: July 22, 2009

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017