Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions

Healthy Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511731
• Other study ID #: 981325
• Status: Completed
• Phase: Phase 1
• First received: January 12, 2012
• Last updated: January 18, 2012
• Start date: October 1998
• Est. completion date: October 1998

Study information

• Verified date: January 2012
• Source: Dr. Reddy's Laboratories Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 subjects completed the clinical phase of the study. Single oral 40 mg doses were separated by a washout period of 7 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 1998
• Est. primary completion date: October 1998
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Famotidine
Famotidine Tablets 40 mg
• Pepcid
40mg tablets

Locations

Country	Name	City	State
Canada	Phoenix Clinical Research Center	Montreal

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Reddy's Laboratories Limited

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No