Trial | NCT01511731  Report issue

Title

Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions
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.

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    famotidine ...

  • Study Participants

    30
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 : 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.
Study Started
Oct 31
1998
Primary Completion
Oct 31
1998
Study Completion
Oct 31
1998
Last Update
Jan 19
2012
Estimate

Drug Famotidine

Famotidine Tablets 40 mg

  • Other names: Reddy Cheminor

Drug Pepcid

40mg tablets

  • Other names: Merck & Co.

Famotidine Experimental

Famotidine tablets 40 mg of Dr. Reddy's

Pepcid Active Comparator

Pepcid 40 mg Tablets of Merck & Co.,

Criteria 

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.
No Results Posted