A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00944671
First received: July 22, 2009
Last updated: June 19, 2015
Last verified: June 2015
  Purpose
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.

Condition Intervention Phase
Heartburn
Drug: famotidine (+) calcium carbonate (+) magnesium hydroxide tablet
Drug: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water
Drug: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water
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/Antacid Combination Tablets (FACT) Compared to Famotidine/Antacid EZ Chew Tablet Without Water and Famotidine/Antacid EZ Chew Tablet With Water

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • 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 [ Time Frame: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose) ] [ Designated as safety issue: No ]
  • Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water [ Time Frame: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose) ] [ Designated as safety issue: No ]
  • Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water [ Time Frame: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose) ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: February 2008
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Famotidine/antacid combination tablet with water
Drug: famotidine (+) calcium carbonate (+) magnesium hydroxide tablet
A single dose of famotidine/antacid tablet with 120 mL of water in one of three treatment periods
Experimental: B
Famotidine/Antacid EZ Chew tablet without water
Drug: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water
A single dose of famotidine/antacid combination EZ Chew tablet without water in one of three treatment periods
Experimental: C
Famotidine/Antacid EZ Chew tablet with water
Drug: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water
A single dose of famotidine/antacid combination EZ Chew tablet with 120 mL of water in one of three treatment periods

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  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: NCT00944671

Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00944671     History of Changes
Other Study ID Numbers: 0208C-145  2009_622 
Study First Received: July 22, 2009
Results First Received: October 27, 2014
Last Updated: June 19, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms
Calcium, Dietary
Calcium Carbonate
Antacids
Magnesium Hydroxide
Famotidine
Anti-Ulcer Agents
Bone Density Conservation Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 28, 2016