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A Pharmacokinetic Study of an Experimental Paracetamol Formulation

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: November 17, 2011
Last updated: November 20, 2014
Last verified: June 2014
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


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

Inclusion Criteria:

  • Healthy volunteer

Exclusion Criteria:

  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 identifier: NCT01476176

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

Responsible Party: GlaxoSmithKline Identifier: NCT01476176     History of Changes
Other Study ID Numbers: A2260665
Study First Received: November 17, 2011
Last Updated: November 20, 2014

Keywords provided by GlaxoSmithKline:
Healthy volunteers

Additional relevant MeSH terms:
Tension-Type Headache
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents processed this record on September 21, 2017