A Relative Bioavailability Study of Acetaminophen 650 mg Extended Release Gelcaps Under Fasting Condition
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)
Links
- Source: http://clinicaltrials.gov/show/NCT01073709
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:15:42-0400
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Medical and Biotech [MESH] Definitions
Healthy People Programs
Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.
Acetaminophen
Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
Pregnenolone Carbonitrile
A catatoxic steroid and microsomal enzyme inducer having significant effects on the induction of cytochrome P450. It has also demonstrated the potential for protective capability against acetaminophen-induced liver damage.
Nutrition Policy
Governmental guidelines and objectives pertaining to public food supply and nutrition including recommendations for healthy diet and changes in food habits to ensure healthy diet.
Nerve Transfer
Surgical reinnervation of a denervated peripheral target using a healthy donor nerve and/or its proximal stump. The direct connection is usually made to a healthy postlesional distal portion of a non-functioning nerve or implanted directly into denervated muscle or insensitive skin. Nerve sprouts will grow from the transferred nerve into the denervated elements and establish contact between them and the neurons that formerly controlled another area.
