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

March 1, 2010 updated by: Ranbaxy Laboratories Limited

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Were in the age range of 18-45 years.
  • Were neither overweight nor underweight for the corresponding height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
  • Had voluntarily given written informed consent to participate in this study.
  • Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.
  • Were non-vegetarian.

There was no deviation in this regard.

Exclusion Criteria:

  • Had a history of hypersensitivity to acetaminophen or to any of the components of the formulation.
  • Had a history of skin rashes, thrombocytopenia, urticaria or angioedema.
  • Had a history of peptic ulcer.
  • Had recent history of nausea and vomiting
  • Showed any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
  • Showed presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
  • Showed presence of values which were significantly different from normal reference ranges defined and/or judged clinically significant for haemoglobin, total white blood cells count, differential WBC count or platelet count.
  • Were positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)
  • Showed presence of values which were significantly different from normal reference ranges and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.
  • Showed clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), epithelial cells (>4/HPF), glucose (positive) or protein (positive).
  • Showed clinically abnormal ECG or Chest X-ray.
  • Had a history of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma.
  • Had a history of any psychiatric illness, which might impair the ability to provide written informed consent.
  • Were regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period.
  • Had history of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or had difficulty in abstaining for the duration of each study period.
  • Used any enzyme modifying drugs within 30 days prior to Day 1 of this study.
  • Participated in any clinical trial within 12 weeks preceding Day 1 of this study.
  • Subjects who, through completion of this study, had donated and/or lost more than 350 mL of blood in the past 3 months.

There was no deviation in this regard.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test
Acetaminophen extended release gelcaps 650 mg of OHM Laboratories Inc. (a subsidiary of Ranbaxy Pharmaceuticals Inc.)
Drug: Acetaminophen
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
Drug: Acetaminophen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bioequivalence evaluation of acetaminophen 650 mg extended release gelcaps under fed conditions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ranbaxy Laboratories Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

February 18, 2010

First Submitted That Met QC Criteria

March 1, 2010

First Posted (Estimate)

March 2, 2010

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

March 1, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 144_ACETA_07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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