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A Pharmacokinetic Study of an Experimental Paracetamol Formulation

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. Identifier: NCT01476176
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : November 24, 2014
Information provided by (Responsible Party):

Brief Summary:
This PK study is designed to show bioequivalence between the study treatments.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : July 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
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

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

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

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

Inclusion Criteria:

  • Healthy volunteer

Exclusion Criteria:


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 identifier (NCT number): NCT01476176

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

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Responsible Party: GlaxoSmithKline Identifier: NCT01476176     History of Changes
Other Study ID Numbers: A2260665
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: November 24, 2014
Last Verified: June 2014
Keywords provided by GlaxoSmithKline:
Healthy volunteers
Additional relevant MeSH terms:
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Tension-Type Headache
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
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