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Completed

NCT Number: NCT01540721

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

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

Completed

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Key information

Conditions

Healthy Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MDS Pharma Services NEBRASKA

Lincoln, Nebraska, 68501, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Marketed paracetamol

Drug

marketed formulation

Experimental paracetamol formulation

Drug

Experimental formulation

Primary outcomes

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

    Time frame: baseline to 12 hours

  2. 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

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

    Time frame: baseline to 12 hours

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 29, 2012
Registry last updated
Nov 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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