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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Heartburn

Treatments: Drug: Famotidine FCT; Drug: Famotidine CT

Study type: Interventional

Funder types: Industry

Identifiers

NCT00945750

0208-144

2009_621 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 6 patient groups

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

Experimental group

Description:

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).

Treatment:

Drug: Famotidine FCT

Drug: Famotidine CT

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

Experimental group

Description:

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).

Treatment:

Drug: Famotidine FCT

Drug: Famotidine CT

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

Experimental group

Description:

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).

Treatment:

Drug: Famotidine FCT

Drug: Famotidine CT

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

Experimental group

Description:

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).

Treatment:

Drug: Famotidine FCT

Drug: Famotidine CT

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

Experimental group

Description:

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).

Treatment:

Drug: Famotidine FCT

Drug: Famotidine CT

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

Experimental group

Description:

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).

Treatment:

Drug: Famotidine FCT

Drug: Famotidine CT