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Pharmacokinetic Study to Compare Two Formulations of Paracetamol

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01767428
First Posted: January 14, 2013
Last Update Posted: January 14, 2013
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
A pharmacokinetic study in healthy volunteers comparing two formulations of paracetamol fast release in fasted state.

Condition Intervention Phase
Fever Headache Disorders Pain Drug: Paracetamol Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Study to Evaluate the Rate and Extent of Absorption of Paracetamol From Two Formulations in an Indian Population.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • AUC (0-inf) [ Time Frame: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose. ]
    Area under the plasma concentration time curve from zero and extrapolated to infinite time.

  • Cmax [ Time Frame: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose. ]
    Maximum plasma concentration of paracetamol.

  • AUC (0-t) [ Time Frame: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose. ]
    Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample.


Secondary Outcome Measures:
  • Tmax [ Time Frame: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose. ]
    Time taken to reach maximum plasma concentration of paracetamol.


Enrollment: 30
Study Start Date: April 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Paracetamol Tablet
Experimental paracetamol tablet (500 milligrams [mg]) administered with 240 milliliters (mL) of water.
Drug: Paracetamol
500 mg immediate release paracetamol formulations
Active Comparator: Standard Paracetamol Tablet (500 mg)
Standard paracetamol tablet (500 mg) administered with 240 mL of water.
Drug: Paracetamol
500 mg immediate release paracetamol formulations

  Eligibility

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:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteers aged 18-55yrs willing to give written informed consent for the study
  • BMI must be within the range 18.5 - 24.9 kg/m^2
  • Participant with a minimum weight of 50 kg

Exclusion Criteria:

  • Participant with current or recurrent disease that could affect the action, absorption or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure)
  • Participant with known or suspected intolerance or hypersensitivity to the study materials
  • Participant who are vegetarian
  • Participant smoking more than five cigarettes a day
  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): NCT01767428


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01767428     History of Changes
Other Study ID Numbers: A1900832
First Submitted: December 6, 2012
First Posted: January 14, 2013
Last Update Posted: January 14, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Headache
Headache Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics