We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Pharmacokinetic Study of an Experimental Paracetamol Formulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01476176
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
This PK study is designed to show bioequivalence between the study treatments.

Condition Intervention Phase
Headache, Tension-Type Drug: Experimental paracetamol Drug: Paracetamol marketed formulation Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: A Pivotal Pharmacokinetic Study Investigating the Extent of Absorptions of Paracetamol and Caffeine for Two Different Paracetomol Formulations Containing Caffeine

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • PK variables (AUC 0-10hrs, AUC 0-inf, and Cmax) to determine bioequivalence [ Time Frame: 10 hours ]

Secondary Outcome Measures:
  • PK variables to compare speed of absorption (AUC 0-30min, AUC 0-60min, Tmax) [ Time Frame: 10 hours ]

Enrollment: 30
Study Start Date: July 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental paracetamol formulation
experimental formulation
Drug: Experimental paracetamol
experimental paracetamol with caffeine
Active Comparator: paracetamol marketed formulation
Paracetamol marketed formulation
Drug: Paracetamol marketed formulation
marketed formulation containing caffeine

  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:

  • Healthy volunteer

Exclusion Criteria:

  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): NCT01476176


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: NCT01476176     History of Changes
Other Study ID Numbers: A2260665
First Submitted: November 17, 2011
First Posted: November 22, 2011
Last Update Posted: November 24, 2014
Last Verified: June 2014

Keywords provided by GlaxoSmithKline:
Bioequivalence
Pharmacokinetics
Healthy volunteers
paracetamol
caffeine

Additional relevant MeSH terms:
Headache
Tension-Type Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Acetaminophen
Caffeine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents