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A Pharmacokinetic Study of an Experimental Paracetamol Formulation

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

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

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 ]


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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:


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov 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:
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