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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Marketed paracetamol; Drug: Higher dose marketed paracetamol; Drug: Experimental paracetamol formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01476189

A2750607

Details and patient eligibility

About

A repeat 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 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.

Trial design

28 participants in 3 patient groups

Experimental paracetamol formulation

Experimental group

Description:

test formulation

Treatment:

Drug: Experimental paracetamol formulation

Marketed paracetamol

Active Comparator group

Description:

Marketed paracetamol

Treatment:

Drug: Marketed paracetamol

Higher dose marketed paracetamol

Active Comparator group

Description:

higher dose marketed paracetamol

Treatment:

Drug: Higher dose marketed paracetamol