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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00945750
First received: July 22, 2009
Last updated: November 4, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Heartburn
Drug: Famotidine FCT
Drug: Famotidine CT
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: August 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1: FCT with water → CT without water → CT with water
Participants received famotidine 20 mg FCT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 3).
Drug: Famotidine FCT
Famotidine 20 mg oral film-coated tablet taken once daily
Drug: Famotidine CT
Famotidine 20 mg oral chewable tablet taken once daily
Experimental: Sequence 2: CT without water → CT with water → FCT with water
Participants received famotidine 20 mg CT as a single dose without water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 3).
Drug: Famotidine FCT
Famotidine 20 mg oral film-coated tablet taken once daily
Drug: Famotidine CT
Famotidine 20 mg oral chewable tablet taken once daily
Experimental: Sequence 3: CT with water → FCT with water → CT without water
Participants received famotidine 20 mg CT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 3).
Drug: Famotidine FCT
Famotidine 20 mg oral film-coated tablet taken once daily
Drug: Famotidine CT
Famotidine 20 mg oral chewable tablet taken once daily
Experimental: Sequence 4: FCT with water → CT with water → CT without water
Participants received famotidine 20 mg FCT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 3).
Drug: Famotidine FCT
Famotidine 20 mg oral film-coated tablet taken once daily
Drug: Famotidine CT
Famotidine 20 mg oral chewable tablet taken once daily
Experimental: Sequence 5: CT without water → FCT with water → CT with water
Participants received famotidine 20 mg CT as a single dose without water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 3).
Drug: Famotidine FCT
Famotidine 20 mg oral film-coated tablet taken once daily
Drug: Famotidine CT
Famotidine 20 mg oral chewable tablet taken once daily
Experimental: Sequence 6: CT with water → CT without water → FCT with water
Participants received famotidine 20 mg CT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 3).
Drug: Famotidine FCT
Famotidine 20 mg oral film-coated tablet taken once daily
Drug: Famotidine CT
Famotidine 20 mg oral chewable tablet taken once daily

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945750

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00945750     History of Changes
Other Study ID Numbers: 0208-144  2009_621 
Study First Received: July 22, 2009
Results First Received: August 17, 2015
Last Updated: November 4, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms
Famotidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2016