Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Area Under Curve (AUC) [ Time Frame: 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. ] [ Designated as safety issue: No ]
|Study Start Date:||October 1998|
|Study Completion Date:||October 1998|
|Primary Completion Date:||October 1998 (Final data collection date for primary outcome measure)|
Famotidine tablets 40 mg of Dr. Reddy's
Famotidine Tablets 40 mg
Other Name: Reddy Cheminor
Active Comparator: Pepcid
Pepcid 40 mg Tablets of Merck & Co.,
Other Name: Merck & Co.
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.