Clinical trial NCT00944671: A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED)
Official title: A Single-Dose, Open-Label, Three-Period Crossover Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets (FACT) Compared to Famotidine/Antacid EZ Chew Tablet Without Water and Famotidine/Antacid EZ Chew Tablet With Water
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heartburn
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2009-07-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study in 24 healthy subjects to assess the bioequivalence of Famotidine/Antacid EZ Chew tablet taken without water and with water compared to the Famotidine/Antacid tablet taken with water. Subjects will be given a single dose of each treatment separated by 5 to 7 days.


Eligibility 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 a history of stomach ulcers, other Gastrointestinal (GI) diseases or GI surgery
* 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

Primary outcomes:
measure: Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water
timeFrame: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
measure: Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water
timeFrame: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
Secondary outcomes:
measure: Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water
timeFrame: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
measure: Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water
timeFrame: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: