Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol®

Phase 1

Completed

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

• Registration Number: NCT01540734
• Lead Sponsor: GlaxoSmithKline

Brief Summary

A single dose pharmacokinetic study investigating two paracetamol formulations

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-23
• Study First Posted: 2012-02-29
• 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 heatlh 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 remainder of 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
To compare bioavailability as measured by Area under the Curve in both fed and fasted states	Visit 1 through Visit 3 (Day 13)
To assess the effect of food on extent and rate of paracetamol absorption as measured by Area Under the Curve and Cmax	Visit 1 through Visit 3 (Day 13)

Secondary Outcome Measures

Name	Time	Method
To assess descriptive pharmacokinetic characteristics (Tmax, T1/2, AUC, Cmax)	Visit 1 through Visit 3 (Day 13)

Trial Locations

Locations (1)

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