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

NCT00944671 | Completed Phase 1 Results

• 2 other identifiers: 0208C-1452009_622
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heartburn

Outcome Measures

Primary Outcomes (2)

• 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

  Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)

• Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water

  Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)

Secondary Outcomes (2)

• 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

  Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)

• Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water

  Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)

Study Arms (3)

A

ACTIVE COMPARATOR

Famotidine/antacid combination tablet with water

Drug: famotidine (+) calcium carbonate (+) magnesium hydroxide tablet

B

EXPERIMENTAL

Famotidine/Antacid EZ Chew tablet without water

Drug: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water

C

EXPERIMENTAL

Famotidine/Antacid EZ Chew tablet with water

Drug: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water

Interventions

famotidine (+) calcium carbonate (+) magnesium hydroxide tablet DRUG

A single dose of famotidine/antacid tablet with 120 mL of water in one of three treatment periods

A

Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water DRUG

A single dose of famotidine/antacid combination EZ Chew tablet without water in one of three treatment periods

B

Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water DRUG

A single dose of famotidine/antacid combination EZ Chew tablet with 120 mL of water in one of three treatment periods

C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

MeSH Terms

Conditions

Heartburn

Interventions

Famotidine; Calcium Carbonate; Magnesium Hydroxide; Water

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Hydroxides; Alkalies; Anions; Ions; Electrolytes; Magnesium Compounds; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Executive Vice President, Clinical and Quantitative Sciences
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: July 23, 2009
• Study Start: February 1, 2008
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: June 24, 2015
• Results First Posted: June 24, 2015

Record last verified: 2015-06