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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01540721

A2750605

Details and patient eligibility

About

This study will evaluate the pharmacokinetic profiles of experimental formulations of paracetamol.

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Current (within 14 days of screening) or regular use of any prescription, over the counter (OTC) drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism, excluding prescription birth control, if applicable.

Trial design

28 participants in 2 patient groups

Experimental paracetamol formulation

Experimental group

Description:

Experimental formulation

Treatment:

Drug: Experimental paracetamol formulation

Marketed paracetamol

Active Comparator group

Description:

Marketed formulation

Treatment:

Drug: Marketed paracetamol