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Completed

NCT Number: NCT01476189

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

A repeat 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 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.

Treatment and study plan

Experimental paracetamol formulation

Drug

experimental

Marketed paracetamol

Drug

Marketed paracetamol

Higher dose marketed paracetamol

Drug

Higher dose marketed paracetamol

Primary outcomes

  1. Bioequivalence as measured by Area Under the Curve (AUC)

    Time frame: last 24 hours of dosing

Secondary outcomes

  1. Time duration at or above minimal therapeutic plasma paracetamol concentration

    Time frame: last 24 hours of dosing

  2. To assess pharmacokinetic parameters (Cmax, AUC, Tmax and Kel)

    Time frame: last 24 hours of dosing

  3. Adverse events

    Time frame: Baseline to 72 hours post dosing

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Repeat 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
Nov 22, 2011
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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