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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ranbaxy Inc. ( Ranbaxy Laboratories Limited )
ClinicalTrials.gov Identifier:
NCT01523080
First received: January 27, 2012
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

The study was to compare single-dose oral bioavailability of acetaminophen 650 mg extended release geltabs (containing acetaminophen 650 mg) of OHM Laboratories Inc. (subsidiary of Ranbaxy Pharmaceuticals Inc., USA) with Tylenol 8 hour extended release gel tabs (containing acetaminophen 650 mg) of McNeil Consumer & Speciality Pharmaceuticals, U.S.A in healthy, adult, male human 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, Randomised, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioavailability Study Comparing Acetaminophen 650 mg Extended Release Gel Tabs (Containing Acetaminophen 650 mg) of OHM Laboratories Inc. (Subsidiary of Ranbaxy) With Tylenol 8 Hour Extended Release Gel Tabs (Containing Acetaminophen 650 mg) of McNeil Consumer & Speciality Pharmaceuticals 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:
  • Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Acetaminophen [ Time Frame: 0, 0.167, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16 and 24 hours ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: May 2006
Study Completion Date: July 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tylenol® 650 mg
Tylenol® 650 mg of McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, INC. Fort Washington, PA 19034 USA.
Drug: Acetaminophen
Extended release Gel tabs 650 mg
Experimental: Acetaminophen extended release Gel tabs 650 mg
Acetaminophen extended release Gel tabs 650 mg of OHM Laboratories Inc. (A subsidiary of Ranbaxy Pharmaceuticals Inc., USA)
Drug: Acetaminophen
Extended release Gel tabs 650 mg

Detailed Description:

The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single dose, crossover bioavailability study comparing acetaminophen 650 mg extended release gel tabs (containing acetaminophen 650 mg) of OHM Laboratories Inc. (subsidiary of Ranbaxy) with Tylenol 8 hour extended release gel tabs (containing acetaminophen 650 mg) of McNeil Consumer & Speciality Pharmaceuticals in healthy, adult, human, male subjects under fasting condition.

The treatments were assigned to the study subjects according to SAS generated randomization schedule. Each subject received a single oral dose either Test or Reference product in each period with 240ml of water at ambient temperature after an overnight fast of at least 10 hours under supervision of a trained study personnel.

During the course of the study, safety parameters inclusive of vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical, serology parameters and urine analysis) at base line were assessed. Laboratory parameters of hematology and biochemistry were repeated at the end of the study.

  Eligibility

Ages Eligible for Study:   19 Years to 39 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.

Exclusion Criteria:

  • History of hypersensitivity to Acetaminophen or to any of the components of the formulation.
  • History of skin rashes, thrombocytopenia, urticaria or angioedema
  • 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 that 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 (rise of pressure inside the eye leading to blurring or loss of vision)
  • 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 had 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.
  • Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study.
  • Participation in any clinical trial within 12 weeks preceding Day 1 of this study.
  • Subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in the past 3 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523080

Locations
India
Clinical Pharmacology Unit, Majeedia Hospital (2nd Floor)
New Delhi, India, 110 062
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Ranbaxy Inc. ( Ranbaxy Laboratories Limited )
ClinicalTrials.gov Identifier: NCT01523080     History of Changes
Other Study ID Numbers: 104_ACETA_06
Study First Received: January 27, 2012
Last Updated: February 8, 2012
Health Authority: India: Drugs Controller General of India

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

ClinicalTrials.gov processed this record on September 18, 2014