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

Study Overview
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Brief Summary
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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.

Official Title
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A Single-Dose, Open-Label, Three-Period Crossover Study to Assess the Bioequivalence of Famotidine 20 mg Film-Coated Tablets (FCT) Compared to Famotidine 20 mg Chewable Tablets (CT) Without Water and Famotidine 20 mg Chewable Tablets (CTw) With Water (Protocol 144)

Conditions
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Heartburn

Intervention / Treatment
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* Drug: Famotidine FCT
* Drug: Famotidine CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1: FCT with water → CT without water → CT with water<br>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<br>* Famotidine 20 mg oral film-coated tablet taken once daily<br>Drug: Famotidine CT<br>* Famotidine 20 mg oral chewable tablet taken once daily<br>|
| Experimental: Sequence 2: CT without water → CT with water → FCT with water<br>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<br>* Famotidine 20 mg oral film-coated tablet taken once daily<br>Drug: Famotidine CT<br>* Famotidine 20 mg oral chewable tablet taken once daily<br>|
| Experimental: Sequence 3: CT with water → FCT with water → CT without water<br>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<br>* Famotidine 20 mg oral film-coated tablet taken once daily<br>Drug: Famotidine CT<br>* Famotidine 20 mg oral chewable tablet taken once daily<br>|
| Experimental: Sequence 4: FCT with water → CT with water → CT without water<br>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<br>* Famotidine 20 mg oral film-coated tablet taken once daily<br>Drug: Famotidine CT<br>* Famotidine 20 mg oral chewable tablet taken once daily<br>|
| Experimental: Sequence 5: CT without water → FCT with water → CT with water<br>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<br>* Famotidine 20 mg oral film-coated tablet taken once daily<br>Drug: Famotidine CT<br>* Famotidine 20 mg oral chewable tablet taken once daily<br>|
| Experimental: Sequence 6: CT with water → CT without water → FCT with water<br>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<br>* Famotidine 20 mg oral film-coated tablet taken once daily<br>Drug: Famotidine CT<br>* Famotidine 20 mg oral chewable tablet taken once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water | AUC 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 | 
| Cmax of Famotidine Following Single Dose Administration of Famotidine CT With 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 |