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OpenTrials
Completed

NCT Number: NCT01592227

A Study to Compare Two Paracetamol Formulations.

A pharmacokinetic study investigating the rate and extent of absorption of paracetamol and an adjuvant from two different paracetamol formulations.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MDS Pharma Services ARIZONA

Phoenix, Arizona, 85044, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male or female volunteers aged 18-55 years with a body mass index ranging from 19-28 kilograms per square meter who have given informed consent

Treatment and study plan

Marketed paracetamol

Drug

Marketed paracetamol

Experimental paracetamol formulation

Drug

Experimental paracetamol formulation

Primary outcomes

  1. Bioequivalence as measured by AUC and Cmax in fasted and semi-fed states

    Time frame: baseline to 10 hours post dose

Secondary outcomes

  1. Speed of absorption in fasted and semi-fed states

    Time frame: baseline to 10 hours post dose

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Pharmacokinetic Study Investigating the Rate and Extent of Absorption of Paracetamol and an Adjuvant From Two Different Paracetamol Formulations.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 7, 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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