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

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT01073709
First received: February 18, 2010
Last updated: February 22, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention
Healthy
Drug: Acetaminophen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover, Bioavailability Study Comparing Acetaminophen 650 mg Extended Release Gelcaps of OHM Laboratories (a Subsidiary of Ranbaxy Pharmaceuticals Inc.), With Tylenol® Arthritis Pain Extended Release Caplets (Containing Acetaminophen 650 mg) of Mc Neil-PPC Inc., in Healthy, Adult, Human, Male Subjects Under Fasting Condition.

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Evaluation of Bioequivalence between ranbaxy acetaminophen 650 mg extended release gelcaps and Tylenol® Arthritis Pain extended release caplets (containing acetaminophen 650 mg) of Mc Neil-PPC Inc.,under fasting conditions [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: November 2007
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Were in the age range of 18-45 years.
  • Were neither overweight nor underweight for his 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.

There were no deviations in this regard.

Exclusion Criteria:

  • History of hypersensitivity to acetaminophen or other related drugs.
  • History of skin rashes, thrombocytopenia, urticaria or angioedema.
  • History of peptic ulcer disease.
  • Recent history of nausea and vomiting
  • Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
  • Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
  • Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for haemoglobin, total white blood cells count, differential WBC count or platelet count.
  • Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)
  • 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.
  • 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).
  • Clinically abnormal ECG or Chest X-ray.
  • History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma.
  • History of any psychiatric illness, which might impair the ability to provide written informed consent.
  • Regular smokers who smoked more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
  • 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.
  • Had used of 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, would had donated and/or lost more than 350 mL of blood in the past 3 months.

There was no deviation in this regard.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073709

Locations
India
Clinical Pharmacology Unit, Majeedia Hospital (2nd Floor)
New Delhi, India
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Tausif Monif, Ranbaxy Research Laboratories
ClinicalTrials.gov Identifier: NCT01073709     History of Changes
Other Study ID Numbers: 143_ACETA_07
Study First Received: February 18, 2010
Last Updated: February 22, 2010
Health Authority: India: Drugs Controller General of India

Keywords provided by Ranbaxy Inc.:
Acetaminophen fasting study

Additional relevant MeSH terms:
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014