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Completed

NCT Number: NCT01767428

Pharmacokinetic Study to Compare Two Formulations of Paracetamol

A pharmacokinetic study in healthy volunteers comparing two formulations of paracetamol fast release in fasted state.

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Key information

Conditions

Fever Body Temperature Changes Brain Diseases Central Nervous System Diseases Headache Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male volunteers aged 18-55yrs willing to give written informed consent for the study
  • BMI must be within the range 18.5 - 24.9 kg/m^2
  • Participant with a minimum weight of 50 kg

Exclusion criteria

  • Participant with current or recurrent disease that could affect the action, absorption or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure)
  • Participant with known or suspected intolerance or hypersensitivity to the study materials
  • Participant who are vegetarian
  • Participant smoking more than five cigarettes a day

Treatment and study plan

Paracetamol

Drug

500 mg immediate release paracetamol formulations

Primary outcomes

  1. AUC (0-inf)

    Time frame: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.

    Area under the plasma concentration time curve from zero and extrapolated to infinite time.

  2. Cmax

    Time frame: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.

    Maximum plasma concentration of paracetamol.

  3. AUC (0-t)

    Time frame: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.

    Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample.

Secondary outcomes

  1. Tmax

    Time frame: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.

    Time taken to reach maximum plasma concentration of paracetamol.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Pharmacokinetic Study to Evaluate the Rate and Extent of Absorption of Paracetamol From Two Formulations in an Indian Population.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 14, 2013
Registry last updated
Jan 14, 2013

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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