Clinical trial NCT00945750: A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heartburn
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-07-24
Enrollment: 30
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
measure: Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
Secondary outcomes:
measure: AUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
measure: Cmax of Famotidine Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: