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

A Single Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Different Sustained Released Paracetamol Formulations

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01540721

Enrollment

Registered

2012-02-29

Start date

2009-12-31

Completion date

2009-12-31

Last updated

2014-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

paracetamol, pharmacokinetics

Brief summary

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

Interventions

DRUGMarketed paracetamol

marketed formulation

DRUGExperimental paracetamol formulation

Experimental formulation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Bioavailability as measured by Area Under the Curve (AUC) in both fasted and fed state	baseline to 12 hours
Effect of food on the extent and rate of paracetamol absorption as measured by AUC and Cmax	baseline to 12 hours

Secondary

Measure	Time frame
To assess descriptive pharmaokinetic characteristics (Tmax, T1/2, Cmax, AUC)	baseline to 12 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026