NCT01513668

Brief Summary

The purpose of this study is to compare single-dose oral bioavailability of acetaminophen 650 mg extended release geltabs (containing acetaminophen 650 mg) of OHM Laboratories, USA (subsidiary of Ranbaxy) with Tylenol extended release geltabs (containing acetaminophen 650 mg) of Mc Neil, Consumer \& Specialty Pharmaceuticals, U.S.A in healthy, adult, male human subjects under fed condition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started May 2006

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

Same day

First QC Date

January 16, 2012

Last Update Submit

January 27, 2012

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Acetaminophen

    0 to 24 hours

Study Arms (2)

Acetaminophen extended release Gel tabs

EXPERIMENTAL

Acetaminophen extended release Gel tabs 650 mg of OHM Laboratories Inc. (A subsidiary of Ranbaxy Pharmaceuticals Inc., USA)

Drug: Acetaminophen

Tylenol® 650 mg

ACTIVE COMPARATOR

Tylenol® 650 mg of McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, INC. Fort Washington, PA 19034 USA

Drug: Acetaminophen

Interventions

AcetaminophenDRUG

Extended release Gel tabs 650 mg

Acetaminophen extended release Gel tabsTylenol® 650 mg

Eligibility Criteria

Age18 Years - 39 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-45 years.
  • Had a non-vegetarian diet.
  • Were neither overweight nor underweight for their 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.

You may not qualify if:

  • Had history of hypersensitivity to acetaminophen or to any of the components of the formulation.
  • Had any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
  • Had presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
  • Had 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.
  • Were positive for urinary screen testing of drugs of abuse (opiates or cannabinoids).
  • Had 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.
  • Had clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (\>4/HPF), glucose (positive) or protein (positive).
  • Had clinically abnormal ECG or Chest X-ray.
  • Had history of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes or glaucoma (rise of pressure inside the eye leading to blurring or loss of vision).
  • Had history of any psychiatric illness, which may 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.
  • Had used any enzyme modifying drugs within 30 days prior to Day 1 of this study.
  • Had 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Pharmacology Unit, B-22, Sector 62

Noida, Uttar Pradesh, 201 301, India

Location

Related Links

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2012

First Posted

January 20, 2012

Study Start

May 1, 2006

Primary Completion

May 1, 2006

Study Completion

July 1, 2006

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

IN(1)