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NCT Number: NCT00945750

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

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.

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Key information

Conditions

Heartburn Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Famotidine FCT

Drug

Famotidine 20 mg oral film-coated tablet taken once daily

Famotidine CT

Drug

Famotidine 20 mg oral chewable tablet taken once daily

Primary outcomes

  1. 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

    Time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose

    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.

  2. Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water

    Time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose

    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.

Secondary outcomes

  1. AUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water

    Time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose

    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.

  2. Cmax of Famotidine Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water

    Time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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)

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jul 24, 2009
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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