NCT01079078

A Relative Bioavailability Study of Acetaminophen 650 mg Extended Release Gelcaps Under Fed Condition

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Acetaminophen

Timeline

• Start date: 2007-10-01
• Primary completion: 2007-11-01
• Completion: 2007-12-01
• First posted: 2010-03-02
• Last updated: 2010-03-02

Locations

1 site across 1 country: India