Pharmacokinetic Study to Compare Two Formulations of Paracetamol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01767428
First received: December 6, 2012
Last updated: January 10, 2013
Last verified: January 2013

December 6, 2012
January 10, 2013
April 2010
April 2010   (final data collection date for primary outcome measure)
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample.
Same as current
Complete list of historical versions of study NCT01767428 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
Time taken to reach maximum plasma concentration of paracetamol.
Same as current
Not Provided
Not Provided
 
Pharmacokinetic Study to Compare Two Formulations of Paracetamol
A Pharmacokinetic Study to Evaluate the Rate and Extent of Absorption of Paracetamol From Two Formulations in an Indian Population.

A pharmacokinetic study in healthy volunteers comparing two formulations of paracetamol fast release in fasted state.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Fever
  • Headache Disorders
  • Pain
Drug: Paracetamol
500 mg immediate release paracetamol formulations
  • Experimental: Experimental Paracetamol Tablet
    Experimental paracetamol tablet (500 milligrams [mg]) administered with 240 milliliters (mL) of water.
    Intervention: Drug: Paracetamol
  • Active Comparator: Standard Paracetamol Tablet (500 mg)
    Standard paracetamol tablet (500 mg) administered with 240 mL of water.
    Intervention: Drug: Paracetamol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01767428
A1900832
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP