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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Paracetamol fast dissolution suspension; Drug: Paracetamol; Drug: Paracetamol slow dissolution suspension; Drug: Paracetamol medium dissolution suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT01476215

A3950669

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

18 participants in 4 patient groups

Fast dissolution suspension

Experimental group

Treatment:

Drug: Paracetamol fast dissolution suspension

Medium dissolution suspension

Experimental group

Treatment:

Drug: Paracetamol medium dissolution suspension

Slow dissolution suspension

Experimental group

Treatment:

Drug: Paracetamol slow dissolution suspension

Marketed suspension

Active Comparator group

Treatment:

Drug: Paracetamol