A Study to Compare Two Paracetamol Formulations.

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: Marketed paracetamol; Drug: Experimental paracetamol formulation

• Registration Number: NCT01592227
• Lead Sponsor: GlaxoSmithKline

Brief Summary

A pharmacokinetic study investigating the rate and extent of absorption of paracetamol and an adjuvant from two different paracetamol formulations.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2011-11-17
• Study First Submitted QC: 2012-05-03
• Study First Posted: 2012-05-07
• Status Verified: 2014-06
• Last Update Submitted: 2014-11-20
• Last Update Posted: 2014-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Healthy male or female volunteers aged 18-55 years with a body mass index ranging from 19-28 kilograms per square meter who have given informed consent

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Bioequivalence as measured by AUC and Cmax in fasted and semi-fed states	baseline to 10 hours post dose

Secondary Outcome Measures

Name	Time	Method
Speed of absorption in fasted and semi-fed states	baseline to 10 hours post dose

Trial Locations

Locations (1)

MDS Pharma Services ARIZONA; 🇺🇸 Phoenix, Arizona, United States