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A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01476215
First Posted: November 22, 2011
Last Update Posted: November 24, 2014
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
November 3, 2011
November 22, 2011
November 24, 2014
November 2009
November 2009   (Final data collection date for primary outcome measure)
Time to plasma level above therapeutic level [ Time Frame: baseline to 8 hours ]
Same as current
Complete list of historical versions of study NCT01476215 on ClinicalTrials.gov Archive Site
General PK parameters (e.g. AUC, Tmax, Cmax) [ Time Frame: baseline to 8 hours ]
Same as current
Not Provided
Not Provided
 
A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions
A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions
This proof of principle PK study will allow GSKCH to select the most favorable sustained release formulation among 3 prototypes to move to the next stage of drug development.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy Subjects
  • Drug: Paracetamol fast dissolution suspension
  • Drug: Paracetamol medium dissolution suspension
  • Drug: Paracetamol slow dissolution suspension
  • Drug: Paracetamol
  • Experimental: Fast dissolution suspension
    Intervention: Drug: Paracetamol fast dissolution suspension
  • Experimental: Medium dissolution suspension
    Intervention: Drug: Paracetamol medium dissolution suspension
  • Experimental: Slow dissolution suspension
    Intervention: Drug: Paracetamol slow dissolution suspension
  • Active Comparator: Marketed suspension
    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
18
November 2009
November 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteer
  • Body Mass Index between 19.0 - 28.0 (kg/m2) inclusive
Sexes Eligible for Study: Male
19 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01476215
A3950669
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2014

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