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

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ClinicalTrials.gov Identifier: NCT00944671
Recruitment Status : Completed
First Posted : July 23, 2009
Results First Posted : June 24, 2015
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

Study Description
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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.

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : February 2008
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
  2. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944671


Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00944671    
Other Study ID Numbers: 0208C-145
2009_622
First Posted: July 23, 2009    Key Record Dates
Results First Posted: June 24, 2015
Last Update Posted: June 24, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Heartburn
Signs and Symptoms, Digestive
Calcium, Dietary
Calcium Carbonate
Magnesium Hydroxide
Famotidine
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
 Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Anti-Ulcer Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents