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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01073709
Recruitment Status : Completed
First Posted : February 23, 2010
Last Update Posted : February 23, 2010
Information provided by:
Ranbaxy Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Acetaminophen Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : November 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01073709

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Clinical Pharmacology Unit, Majeedia Hospital (2nd Floor)
New Delhi, India
Sponsors and Collaborators
Ranbaxy Laboratories Limited
Additional Information:
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Responsible Party: Dr. Tausif Monif, Ranbaxy Research Laboratories Identifier: NCT01073709    
Other Study ID Numbers: 143_ACETA_07
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: February 23, 2010
Last Verified: February 2010
Keywords provided by Ranbaxy Inc.:
Acetaminophen fasting study
Additional relevant MeSH terms:
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Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs