A Pharmacokinetic Study of an Experimental Paracetamol Formulation

Phase 1

Completed

• Conditions: Headache, Tension-Type
• Interventions: Drug: Paracetamol marketed formulation; Drug: Experimental paracetamol

• Registration Number: NCT01476176
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This PK study is designed to show bioequivalence between the study treatments.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Study First Submitted: 2011-11-17
• Study First Submitted QC: 2011-11-17
• Study First Posted: 2011-11-22
• 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 volunteer

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
paracetamol marketed formulation	Paracetamol marketed formulation	Paracetamol marketed formulation
Experimental paracetamol formulation	Experimental paracetamol	experimental formulation

Primary Outcome Measures

Name	Time	Method
PK variables (AUC 0-10hrs, AUC 0-inf, and Cmax) to determine bioequivalence	10 hours

Secondary Outcome Measures

Name	Time	Method
PK variables to compare speed of absorption (AUC 0-30min, AUC 0-60min, Tmax)	10 hours

Trial Locations

Locations (1)

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