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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01476189
First Posted: November 22, 2011
Last Update Posted: November 24, 2014
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.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
A repeat dose pharmacokinetic study investigating two paracetamol formulations

Condition Intervention Phase
Healthy Subjects Drug: Experimental paracetamol formulation Drug: Marketed paracetamol Drug: Higher dose marketed paracetamol Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by GlaxoSmithKline:

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

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

Enrollment: 28
Study Start Date: November 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental paracetamol formulation
test formulation
Drug: Experimental paracetamol formulation
experimental
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01476189


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01476189     History of Changes
Other Study ID Numbers: A2750607
First Submitted: November 17, 2011
First Posted: November 22, 2011
Last Update Posted: November 24, 2014
Last Verified: June 2014

Keywords provided by GlaxoSmithKline:
pharmacokinetic
paracetamol
Healthy volunteer
steady state

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