Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions

Study Overview
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Brief Summary
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The objective of this study was to compare the single-dose relative bioavailability of Reddy Cheminor and Merck &Co, pepcid 40 mg famotidine tablets under fasting conditions.

Detailed Description
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Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 30 healthy adult male volunteers. A total of 30 subjects completed the clinical phase of the study. Single oral 40 mg doses were separated by a washout period of 7 days.

Official Title
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Open-label, Randomized, 2-way Crossover Study to Compare the Bioavailability of Reddy Cheminor and Merck &Co, Pepcid Famotidine Tablets 40 mg Under Fasting Conditions.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Famotidine
* Drug: Pepcid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Exclusion Criteria: History or presence of significant: • cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease. In addition, history or presence of: alcoholism or drug abuse within the past year; hypersensitivity or idiosyncratic reaction to famotidine or any other histamine H2-receptor antagonist; Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study. Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood in 14 days, or 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator), 1000 mL of blood in 90 days, 1250 mL of blood in 120 days, 1500 mL of blood in 180 days, 2000 mL of blood in 270 days, 2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days of study start.

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

Sexes Eligible for Study
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Male

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: Famotidine<br>Famotidine tablets 40 mg of Dr. Reddy's | Drug: Famotidine<br>* Famotidine Tablets 40 mg<br>* Other names: Reddy Cheminor;|
| Active Comparator: Pepcid<br>Pepcid 40 mg Tablets of Merck & Co., | Drug: Pepcid<br>* 40mg tablets<br>* Other names: Merck & Co.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve (AUC) |  | predose,0. 5, 1, 1. 33, 1. 67, 2, 2. 33, 2.67, 3, 3. 33, 3. 67, 4, 4. 5, 5, 6, 8, 10, 12, 16 and 24 hours post-dose. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, famotidine, Crossover