Status:
COMPLETED
Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
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
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 s...
Eligibility Criteria
Inclusion
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 1998
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01511731
Start Date
October 1 1998
End Date
October 1 1998
Last Update
January 19 2012
Active Locations (1)
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1
Phoenix Clinical Research Center
Montreal, Canada