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.

NCT01079065 NA COMPLETED

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.

Details

Lead sponsor	Ranbaxy Laboratories Limited
Phase	NA
Status	COMPLETED
Enrolment	32
Start date	2007-11
Completion	2007-12

Conditions

• Healthy

Interventions

• Famotidine

Primary outcomes

• Bioequivalence evaluation of ranbaxy famotidine tablets 20mg with Pepcid® AC Acid reducer famotidine tablets 20 mg under fasting condition

Countries

India