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

NCT00945750 | Completed Phase 1 Results

• 2 other identifiers: 0208-1442009_621
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Heartburn

Outcome Measures

Primary Outcomes (2)

• 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

  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.

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

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

  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.

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

Secondary Outcomes (2)

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

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

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

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

Study Arms (6)

Sequence 1: FCT with water → CT without water → CT with water

EXPERIMENTAL

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; Drug: Famotidine CT

Sequence 2: CT without water → CT with water → FCT with water

EXPERIMENTAL

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; Drug: Famotidine CT

Sequence 3: CT with water → FCT with water → CT without water

EXPERIMENTAL

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; Drug: Famotidine CT

Sequence 4: FCT with water → CT with water → CT without water

EXPERIMENTAL

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; Drug: Famotidine CT

Sequence 5: CT without water → FCT with water → CT with water

EXPERIMENTAL

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; Drug: Famotidine CT

Sequence 6: CT with water → CT without water → FCT with water

EXPERIMENTAL

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; Drug: Famotidine CT

Interventions

Famotidine FCT DRUG

Famotidine 20 mg oral film-coated tablet taken once daily

Sequence 1: FCT with water → CT without water → CT with water; Sequence 2: CT without water → CT with water → FCT with water; Sequence 3: CT with water → FCT with water → CT without water; Sequence 4: FCT with water → CT with water → CT without water; Sequence 5: CT without water → FCT with water → CT with water; Sequence 6: CT with water → CT without water → FCT with water

Famotidine CT DRUG

Famotidine 20 mg oral chewable tablet taken once daily

Sequence 1: FCT with water → CT without water → CT with water; Sequence 2: CT without water → CT with water → FCT with water; Sequence 3: CT with water → FCT with water → CT without water; Sequence 4: FCT with water → CT with water → CT without water; Sequence 5: CT without water → FCT with water → CT with water; Sequence 6: CT with water → CT without water → FCT with water

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Heartburn

Interventions

Famotidine

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

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  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 24, 2009
• Study Start: August 1, 2006
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: March 10, 2017
• Results First Posted: December 9, 2015

Record last verified: 2017-01