Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-10-31

Study Completion Date

1998-10-31

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.

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Famotidine

Famotidine tablets 40 mg of Dr. Reddy's

Group Type EXPERIMENTAL

Famotidine

Intervention Type DRUG

Famotidine Tablets 40 mg

Pepcid

Pepcid 40 mg Tablets of Merck \& Co.,

Group Type ACTIVE_COMPARATOR

Pepcid

Intervention Type DRUG

40mg tablets

Interventions

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Famotidine

Famotidine Tablets 40 mg

Intervention Type DRUG

Pepcid

40mg tablets

Intervention Type DRUG

Other Intervention Names

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Reddy Cheminor Merck & Co.

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes