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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Paracetamol fast dissolution suspension; Drug: Paracetamol medium dissolution suspension; Drug: Paracetamol slow dissolution suspension; Drug: Paracetamol

• Registration Number: NCT01476215
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2011-11-03
• Study First Submitted QC: 2011-11-17
• Study First Posted: 2011-11-22
• Status Verified: 2014-06
• Last Update Submitted: 2014-11-20
• Last Update Posted: 2014-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fast dissolution suspension	Paracetamol fast dissolution suspension	-
Medium dissolution suspension	Paracetamol medium dissolution suspension	-
Slow dissolution suspension	Paracetamol slow dissolution suspension	-
Marketed suspension	Paracetamol	-

Primary Outcome Measures

Name	Time	Method
Time to plasma level above therapeutic level	baseline to 8 hours

Secondary Outcome Measures

Name	Time	Method
General PK parameters (e.g. AUC, Tmax, Cmax)	baseline to 8 hours

Trial Locations

Locations (1)

MDS Pharma Services NEBRASKA; 🇺🇸 Lincoln, Nebraska, United States