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Completed

NCT Number: NCT01540734

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

A single dose pharmacokinetic study investigating two paracetamol formulations

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 general heatlh 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 remainder of 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.

Treatment and study plan

Marketed paracetamol

Drug

Marketed formulation

Experimental paracetamol formulation

Drug

Experimental formulation

Primary outcomes

  1. To compare bioavailability as measured by Area under the Curve in both fed and fasted states

    Time frame: Visit 1 through Visit 3 (Day 13)

  2. To assess the effect of food on extent and rate of paracetamol absorption as measured by Area Under the Curve and Cmax

    Time frame: Visit 1 through Visit 3 (Day 13)

Secondary outcomes

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

    Time frame: Visit 1 through Visit 3 (Day 13)

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 Sustained Release 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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