A Relative Bioavailability Study of Acetaminophen 650 mg Extended Release Gelcaps Under Fed Condition
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single dose, crossover bioavailability study comparing acetaminophen extended release gelcaps 650 mg (containing acetaminophen 650 mg) of OHM Laboratories Inc. with TYLENOLÒ arthritis pain caplets 650 mg (containing acetaminophen 650 mg) of McNeil Consumer & specialty Pharmaceuticals in healthy, adult, human, male subjects under fed condition.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
|Official Title:||An Open Label, Balanced, Randomised, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioavailability Study Comparing Acetaminophen 650 mg Extended Release Gelcaps (Containing Acetaminophen 650 mg) of OHM Laboratories (A Subsidiary of Ranbaxy Pharmaceuticals Inc.) With TylenolÒ Arthritis Pain Extended Release Caplets (Containing Acetaminophen 650 mg) of McNeil-PPC Inc. in Healthy, Adult, Human, Male Subjects Under Fed Condition.|
- Bioequivalence evaluation of acetaminophen 650 mg extended release gelcaps under fed conditions [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Study Completion Date:||December 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
Acetaminophen extended release gelcaps 650 mg of OHM Laboratories Inc. (a subsidiary of Ranbaxy Pharmaceuticals Inc.)
Active Comparator: Reference
Tylenol® Arthritis Pain caplets 650 mg (containing acetaminophen 650 mg)of McNeil Consumer & Specialty Pharmaceuticals, Division of MCNEIL-PPC, Inc. Fort Washington, PA 19034 USA
A single oral dose of acetaminophen 650 mg was administered (except Subject No. 17) with 240 mL of drinking water during each period 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, serology parameters and urine analysis) at base line. Laboratory parameters of hematology and biochemistry were repeated at the end of study (except Glucose and cholesterol).