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Completed

NCT Number: NCT01476176

A Pharmacokinetic Study of an Experimental Paracetamol Formulation

This PK study is designed to show bioequivalence between the study treatments.

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Key information

Conditions

Headache, Tension-Type Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases Tension-Type Headache

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 volunteer

Exclusion criteria

-

Treatment and study plan

Experimental paracetamol

Drug

experimental paracetamol with caffeine

Paracetamol marketed formulation

Drug

marketed formulation containing caffeine

Primary outcomes

  1. PK variables (AUC 0-10hrs, AUC 0-inf, and Cmax) to determine bioequivalence

    Time frame: 10 hours

Secondary outcomes

  1. PK variables to compare speed of absorption (AUC 0-30min, AUC 0-60min, Tmax)

    Time frame: 10 hours

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Pivotal Pharmacokinetic Study Investigating the Extent of Absorptions of Paracetamol and Caffeine for Two Different Paracetomol Formulations Containing Caffeine

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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