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OpenTrials
Completed

NCT Number: NCT01476215

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.

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Key information

Conditions

Healthy Subjects

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

MDS Pharma Services NEBRASKA

Lincoln, Nebraska, 68501, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteer
  • Body Mass Index between 19.0 - 28.0 (kg/m2) inclusive

Treatment and study plan

Paracetamol fast dissolution suspension

Drug

Paracetamol medium dissolution suspension

Drug

Paracetamol slow dissolution suspension

Drug

Paracetamol

Drug

Primary outcomes

  1. Time to plasma level above therapeutic level

    Time frame: baseline to 8 hours

Secondary outcomes

  1. General PK parameters (e.g. AUC, Tmax, Cmax)

    Time frame: baseline to 8 hours

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Nov 22, 2011
Registry last updated
Nov 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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