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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:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01476215
First received: November 3, 2011
Last updated: November 20, 2014
Last verified: June 2014

November 3, 2011
November 20, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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
Male
19 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01476215
A3950669
No
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