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

Phase 1CompletedNCT01540721

GlaxoSmithKline28 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy Subjects

Interventions

Marketed paracetamolDRUG

marketed formulation

Experimental paracetamol formulationDRUG

Experimental formulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

MDS Pharma Services NEBRASKA

Lincoln, Nebraska, United States

Outcomes

Primary Outcomes

Bioavailability as measured by Area Under the Curve (AUC) in both fasted and fed state

Time frame: baseline to 12 hours

Effect of food on the extent and rate of paracetamol absorption as measured by AUC and Cmax

Time frame: baseline to 12 hours

Secondary Outcomes

To assess descriptive pharmaokinetic characteristics (Tmax, T1/2, Cmax, AUC)

Time frame: baseline to 12 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.