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

GlaxoSmithKline18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy Subjects

Interventions

Paracetamol fast dissolution suspensionDRUG

Paracetamol medium dissolution suspensionDRUG

Paracetamol slow dissolution suspensionDRUG

Paracetamol

Eligibility

Sex: MALEMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

MDS Pharma Services NEBRASKA

Lincoln, Nebraska, United States

Outcomes

Primary Outcomes

Time to plasma level above therapeutic level

Time frame: baseline to 8 hours

Secondary Outcomes

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

Time frame: baseline to 8 hours

Data from ClinicalTrials.gov

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