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

2014-08-27 03:15:42 | BioPortfolio

Summary

The study was conducted as an open labeled, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioavailability study comparing acetaminophen extended release gelcaps 650 mg of OHM Laboratories Inc. with Tylenol® Arthritis Pain caplets 650 mg of McNeil Consumer & Specialty Pharmaceuticals, in healthy, adult, human, male subjects under fasting condition.

Description

Following an overnight fast of at least 10 hours, all subjects were administered a single oral dose of acetaminophen 650 mg extended release tablet was administered with 240 mL of drinking water during each period of the study under supervision of trained study personnel. Both test (T) and reference (R) products were administered to the study subjects, one in each period (except subject no 40).

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, urine analysis and urine drug screening) were measured at base line. Laboratory parameters of haematology and biochemistry (except glucose and cholesterol) were repeated at the end of the study.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Healthy

Intervention

Acetaminophen

Location

Clinical Pharmacology Unit, Majeedia Hospital (2nd Floor)
New Delhi
India

Status

Completed

Source

Ranbaxy Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:42-0400

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