A Study to Compare to the Pharmacokinetic Profile of Two Paracetamol Formulations

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: NCT01476189
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : November 24, 2014
Information provided by (Responsible Party):

Brief Summary:
A repeat dose pharmacokinetic study investigating two paracetamol formulations

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Experimental paracetamol formulation Drug: Marketed paracetamol Drug: Higher dose marketed paracetamol Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Repeat Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Sustained Release Paracetamol Formulations
Study Start Date : November 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: Experimental paracetamol formulation
test formulation
Drug: Experimental paracetamol formulation

Active Comparator: Marketed paracetamol
Marketed paracetamol
Drug: Marketed paracetamol
Marketed paracetamol

Active Comparator: Higher dose marketed paracetamol
higher dose marketed paracetamol
Drug: Higher dose marketed paracetamol
Higher dose marketed paracetamol

Primary Outcome Measures :
  1. Bioequivalence as measured by Area Under the Curve (AUC) [ Time Frame: last 24 hours of dosing ]

Secondary Outcome Measures :
  1. Time duration at or above minimal therapeutic plasma paracetamol concentration [ Time Frame: last 24 hours of dosing ]
  2. To assess pharmacokinetic parameters (Cmax, AUC, Tmax and Kel) [ Time Frame: last 24 hours of dosing ]
  3. Adverse events [ Time Frame: Baseline to 72 hours post dosing ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.

Exclusion Criteria:

  • Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visit 2 and throughout the study.
  • Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
  • Current (within 14 days of screening) or regular use of any prescription, over-the-counter drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing (e.g. barbiturates, theophylline, cimetidine, or erythromycin), excluding prescription birth control, if applicable.

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): NCT01476189

United States, Nebraska
MDS Pharma Services NEBRASKA
Lincoln, Nebraska, United States, 68501
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT01476189     History of Changes
Other Study ID Numbers: A2750607
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: November 24, 2014
Last Verified: June 2014

Keywords provided by GlaxoSmithKline:
Healthy volunteer
steady state

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs