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A Study to Compare 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.
ClinicalTrials.gov Identifier: NCT01592227
Recruitment Status : Completed
First Posted : May 7, 2012
Last Update Posted : November 24, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
A pharmacokinetic study investigating the rate and extent of absorption of paracetamol and an adjuvant from two different paracetamol formulations.

Condition or disease Intervention/treatment Phase
Pain Drug: Marketed paracetamol Drug: Experimental paracetamol formulation Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Pharmacokinetic Study Investigating the Rate and Extent of Absorption of Paracetamol and an Adjuvant From Two Different Paracetamol Formulations.
Study Start Date : December 2009
Primary Completion Date : December 2009
Study Completion Date : December 2009
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Marketed paracetamol
Marketed paracetamol
Drug: Marketed paracetamol
Marketed paracetamol
Experimental: Experimental paracetamol formulation
Experimental formulations
Drug: Experimental paracetamol formulation
Experimental paracetamol formulation


Outcome Measures

Primary Outcome Measures :
  1. Bioequivalence as measured by AUC and Cmax in fasted and semi-fed states [ Time Frame: baseline to 10 hours post dose ]

Secondary Outcome Measures :
  1. Speed of absorption in fasted and semi-fed states [ Time Frame: baseline to 10 hours post dose ]

Eligibility Criteria

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
Criteria

Inclusion Criteria:

  • Healthy male or female volunteers aged 18-55 years with a body mass index ranging from 19-28 kilograms per square meter who have given informed consent
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): NCT01592227


Locations
United States, Arizona
MDS Pharma Services ARIZONA
Phoenix, Arizona, United States, 85044
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01592227     History of Changes
Other Study ID Numbers: A6480791
First Posted: May 7, 2012    Key Record Dates
Last Update Posted: November 24, 2014
Last Verified: June 2014

Keywords provided by GlaxoSmithKline:
healthy volunteer
pharmacokinetics
paracetamol

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