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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Experimental paracetamol formulation; Drug: Marketed paracetamol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01540734

A2750606

Details and patient eligibility

About

A single dose pharmacokinetic study investigating two paracetamol formulations

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

28 participants in 2 patient groups

Marketed paracetamol

Active Comparator group

Description:

marketed formulation

Treatment:

Drug: Marketed paracetamol

Experimental paracetamol formulation

Experimental group

Description:

Experimental formulation

Treatment:

Drug: Experimental paracetamol formulation