A Relative Bioavailability Study of 20 mg Famotidine Tablets Under Fasting Condition
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioavailability study comparing famotidine tablets, USP 20 mg manufactured by OHM Laboratories with Pepcid® AC Acid reducer famotidine tablets 20 mg (containing famotidine 20 mg) distributed by Johnson & Johnson. Merck Consumer Pharmaceutical Co. Fort Washington, PA 19034 USA under fasting conditions.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
|Official Title:||An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover Bioavailability Study Comparing Famotidine 20 mg Tablets of OHM Laboratories (a Subsidiary of Ranbaxy Pharmaceutical Inc.) With PEPCID AC Tablets (Containing Famotidine 20 mg) of Johnson & Johnson Merck Consumer Pharmaceutical Co. in Healthy, Adult, Human, Male Subjects Under Fasting Condition.|
- Bioequivalence evaluation of ranbaxy famotidine tablets 20mg with Pepcid® AC Acid reducer famotidine tablets 20 mg under fasting condition [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Study Completion Date:||December 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
Famotidine Tablets, USP 20 mg of OHM Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc., USA)
Active Comparator: Reference
Pepcid® AC Acid reducer famotidine tablets 20 mg of Johnson & Johnson. Merck Consumer Pharmaceutical Co. Fort Washington, PA 19034 USA
Following an overnight fast of at least 10 hour, a single oral dose of famotidine tablets, USP 20 mg or Pepcid® AC Acid reducer famotidine tablets 20 mg (containing famotidine 20 mg) was administered during each period of the study, along with 240 mL of drinking water at ambient temperature and under supervision of trained study personnel.
During the course of the study, safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical parameters, serology and urine analysis) at baseline. Adverse event monitoring was done throughout the study. Laboratory parameters of hematology and biochemistry (except blood glucose and cholesterol) were repeated at the end of the study for all the subjects.