A Study to Compare Two Paracetamol Tablets

GlaxoSmithKline

Overview

This is a single dose pharmacoscintigraphic study investigating the differences in paracetamol absorption between two formulations.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Conditions

Healthy Subjects

Interventions

Marketed paracetamolDRUG

marketed formulation

Experimental paracetamol formulationDRUG

Experimental formulation

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male subjects who are in good general health * Have not exceeded the limits of total radiation exposure (5mSv) allowed in any 12 month period

Locations (2)

BIO-IMAGES Research Ltd.

Glasgow, Scotland, United Kingdom

Bio-Images

Glasgow, Scotland, United Kingdom

Outcomes

Primary Outcomes

Time of onset and completion of disintegration based on release of radiolabeled markers in a fed condition

Time frame: Baseline to 12 hours post dosing

Secondary Outcomes

To assess the gastrointestinal transit by qualitative scintigraphic analysis

Time frame: Baseline to 12 hours post dosing

Data from ClinicalTrials.gov

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