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A Study to Compare Two Paracetamol Formulations.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01592227
First received: November 17, 2011
Last updated: January 24, 2013
Last verified: December 2012
History of Changes
  Purpose

A pharmacokinetic study investigating the rate and extent of absorption of paracetamol and an adjuvant from two different paracetamol formulations.


Condition Intervention Phase
Pain
 Drug: Marketed paracetamol
Drug: Experimental paracetamol formulation
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Pharmacokinetic Study Investigating the Rate and Extent of Absorption of Paracetamol and an Adjuvant From Two Different Paracetamol Formulations.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Bioequivalence as measured by AUC and Cmax in fasted and semi-fed states [ Time Frame: baseline to 10 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Speed of absorption in fasted and semi-fed states [ Time Frame: baseline to 10 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: December 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Marketed paracetamol
Marketed paracetamol
 Drug: Marketed paracetamol
Marketed paracetamol
Experimental: Experimental paracetamol formulation
Experimental formulations
 Drug: Experimental paracetamol formulation
Experimental paracetamol formulation

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01592227     History of Changes
Other Study ID Numbers: A6480791
Study First Received: November 17, 2011
Last Updated: January 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:
healthy volunteer
pharmacokinetics
paracetamol

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

ClinicalTrials.gov processed this record on May 22, 2013