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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01476215

Enrollment

Registered

2011-11-22

Start date

2009-11-30

Completion date

2009-11-30

Last updated

2014-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

paracetamol

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.

Interventions

DRUGParacetamol fast dissolution suspension

DRUGParacetamol medium dissolution suspension

DRUGParacetamol slow dissolution suspension

DRUGParacetamol

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Time to plasma level above therapeutic level	baseline to 8 hours

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026