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: June 19, 2014
Last verified: February 2014
  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:


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
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, see Learn About Clinical Studies.

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: June 19, 2014
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 July 23, 2014