A Study to Compare to the Pharmacokinetic Profile of Two Paracetamol Formulations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01476189
First received: November 17, 2011
Last updated: February 13, 2014
Last verified: September 2013

November 17, 2011
February 13, 2014
November 2009
December 2009   (final data collection date for primary outcome measure)
Bioequivalence as measured by Area Under the Curve (AUC) [ Time Frame: last 24 hours of dosing ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01476189 on ClinicalTrials.gov Archive Site
  • Time duration at or above minimal therapeutic plasma paracetamol concentration [ Time Frame: last 24 hours of dosing ] [ Designated as safety issue: No ]
  • To assess pharmacokinetic parameters (Cmax, AUC, Tmax and Kel) [ Time Frame: last 24 hours of dosing ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Baseline to 72 hours post dosing ] [ Designated as safety issue: Yes ]
  • Time duration at or above minimal therapeutic plasma paracetamol concentration [ Time Frame: last 24 hours of dosing ] [ Designated as safety issue: No ]
  • To assess pharmacokinetic parameters (Cmax, AUC, Tmax and Kel) [ Time Frame: last 24 hours of dosing ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Baseline to 72 hours post dosing ]
Not Provided
Not Provided
 
A Study to Compare to the Pharmacokinetic Profile of Two Paracetamol Formulations
A Repeat Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Sustained Release Paracetamol Formulations

A repeat dose pharmacokinetic study investigating two paracetamol formulations

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy Subjects
  • Drug: Experimental paracetamol formulation
    experimental
  • Drug: Marketed paracetamol
    Marketed paracetamol
  • Drug: Higher dose marketed paracetamol
    Higher dose marketed paracetamol
  • Experimental: Experimental paracetamol formulation
    test formulation
    Intervention: Drug: Experimental paracetamol formulation
  • Active Comparator: Marketed paracetamol
    Marketed paracetamol
    Intervention: Drug: Marketed paracetamol
  • Active Comparator: Higher dose marketed paracetamol
    higher dose marketed paracetamol
    Intervention: Drug: Higher dose marketed paracetamol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.

Exclusion Criteria:

  • Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visit 2 and throughout the study.
  • Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
  • Current (within 14 days of screening) or regular use of any prescription, over-the-counter drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing (e.g. barbiturates, theophylline, cimetidine, or erythromycin), excluding prescription birth control, if applicable.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01476189
A2750607
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2013

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