A Study to Compare Two Paracetamol Tablets

Phase 1

Withdrawn

• Conditions: Healthy Subjects
• Interventions: Drug: Marketed paracetamol; Drug: Experimental paracetamol formulation

• Registration Number: NCT01381640
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-06-23
• Study First Posted: 2011-06-27
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-05
• Last Update Posted: 2016-07-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Marketed paracetamol	Marketed paracetamol	Marketed formulation
Experimental paracetamol formulation	Experimental paracetamol formulation	Experimental formulation

Primary Outcome Measures

Name	Time	Method
Time of onset and completion of disintegration based on release of radiolabeled markers in a fed condition	Baseline to 12 hours post dosing

Secondary Outcome Measures

Name	Time	Method
To assess the gastrointestinal transit by qualitative scintigraphic analysis	Baseline to 12 hours post dosing

Trial Locations

Locations (2)

Bio-Images; 🇬🇧 Glasgow, Scotland, United Kingdom

BIO-IMAGES Research Ltd.; 🇬🇧 Glasgow, Scotland, United Kingdom