A Study to Compare to the Pharmacokinetic Profile of Two Paracetamol Formulations

Phase 1

Completed

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

• Registration Number: NCT01476189
• Lead Sponsor: GlaxoSmithKline

Brief Summary

A repeat dose pharmacokinetic study investigating two paracetamol formulations

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2009-12
• Study Completion: 2009-12
• 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: 28

Inclusion Criteria

• Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.

Exclusion Criteria

• Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visit 2 and throughout the study.
• Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
• Current (within 14 days of screening) or regular use of any prescription, over-the-counter drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing (e.g. barbiturates, theophylline, cimetidine, or erythromycin), excluding prescription birth control, if applicable.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental paracetamol formulation	Experimental paracetamol formulation	test formulation
Marketed paracetamol	Marketed paracetamol	Marketed paracetamol
Higher dose marketed paracetamol	Higher dose marketed paracetamol	higher dose marketed paracetamol

Primary Outcome Measures

Name	Time	Method
Bioequivalence as measured by Area Under the Curve (AUC)	last 24 hours of dosing

Secondary Outcome Measures

Name	Time	Method
Adverse events	Baseline to 72 hours post dosing
Time duration at or above minimal therapeutic plasma paracetamol concentration	last 24 hours of dosing
To assess pharmacokinetic parameters (Cmax, AUC, Tmax and Kel)	last 24 hours of dosing

Trial Locations

Locations (1)

MDS Pharma Services NEBRASKA; 🇺🇸 Lincoln, Nebraska, United States