NCT01513668

A Relative Bioavailability Study of Acetaminophen Extended Release Gel Tabs 650 mg 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 Gel Tabs (Containing Acetaminophen 650 mg) of OHM Laboratories (Subsidiary of Ranbaxy) With Tylenol 8 Hour 650 mg Gel Tabs (Containing Acetaminophen 650 mg) of Mc Neil, Consumer & Speciality Pharmaceuticals in Healthy, Adult, Human, Male Subjects Under Fed Condition

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare single-dose oral bioavailability of acetaminophen 650 mg extended release geltabs (containing acetaminophen 650 mg) of OHM Laboratories, USA (subsidiary of Ranbaxy) with Tylenol extended release geltabs (containing acetaminophen 650 mg) of Mc Neil, Consumer \& Specialty Pharmaceuticals, U.S.A in healthy, adult, male human subjects under fed condition.

Detailed description

The study was conducted as open label, balanced, randomised, two-treatment, two-period, two-sequence, single dose, crossover bioavailability study comparing acetaminophen 650 mg extended release gel tabs (containing acetaminophen 650 mg) of OHM Laboratories (subsidiary of Ranbaxy) with Tylenol 8 Hour 650 mg extended release gel tabs (containing acetaminophen 650 mg) of Mc Neil, Consumer \& Specialty Pharmaceuticals in healthy, adult, human, male subjects under fed condition. The treatments were assigned to the study subjects according to SAS generated randomization schedule. Each subject received a single oral dose either Test or Reference product in each period with 240ml of water at ambient temperature, 30 minutes after start of a high-fat high calorie breakfast during each period of the study under supervision of a trained medical officer. During the course of study, the safety parameters including vital signs, physical examination, medical history, clinical laboratory and safety tests (haematology, biochemical parameters) were assessed and clinical laboratory safety tests (hematology \& biochemical parameters) were performed again at the end of the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Acetaminophen	Extended release Gel tabs 650 mg

Timeline

• Start date: 2006-05-01
• Primary completion: 2006-05-01
• Completion: 2006-07-01
• First posted: 2012-01-20
• Last updated: 2012-01-31

Locations

1 site across 1 country: India