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NCT Number: NCT01551797

A Pharmacokinetic Study to Compare Sustained Release and Standard Paracetamol Formulations.

This proof of principle study will evaluate an experimental formulation of paracetamol that is being developed for eventual long lasting use. This study is also used for drug safety evaluation.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charles River Clinical Services Northwest, Inc.

Tacoma, Washington, 98481, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body Mass Index (BMI): Body Mass Index must be in the range 19-28 kg/m2.

Exclusion criteria

  • Disease: Current or recurrent disease that could affect the action, absorption, elimination or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders evidenced by abnormal liver function test, hepatitis serology test and liver image studies, renal insufficiency, congestive heart failure).
  • Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.

Treatment and study plan

Paracetamol 500 mg

Drug

Standard Paracetamol formulation

Paracetamol 1000 mg

Drug

Paracetamol Sustained Release formulation

Paracetamol 750 mg

Drug

Paracetamol Sustained Release formulation

Primary outcomes

  1. Median time to reach therapeutic plasma concentration of paracetamol

    Time frame: Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment

    Time period in hours over which plasma paracetamol concentration is elevated at or above 4 micrograms (μg)/milliliter (mL).

Secondary outcomes

  1. Area under the plasma concentration-time curve (AUC)

    Time frame: Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment

    Area under the plasma concentration-time curve from zero to 6 hours (AUC 0-6 hours), 12 hours (AUC 0-12 hours) to be determined. AUC0-t : the area under the plasma concentration-time curve from zero to time t when paracetamol remains detectable. AUC0-∞: the area under the plasma concentration time curve from zero and extrapolated to infinity time.

  2. Time to maximum plasma concentration (Tmax)

    Time frame: Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment

    Tmax for paracetamol to be determined.

  3. Half-life of elimination (T 1/2)

    Time frame: Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment

    T 1/2 of paracetamol to be determined.

  4. Elimination rate (Kel)

    Time frame: Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment

    Kel of paracetamol to be determined.

  5. Maximum plasma concentration (Cmax)

    Time frame: Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment

    Cmax of paracetamol to be determined.

  6. Number of participants with Adverse Events (AEs) and Serious AEs

    Time frame: Day 1 through Day 14 (follow-up visit)

    Safety evaluation

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Proof of Principal Study to Investigate the Pharmacokinetic Profiles of Sustained Release and Standard Paracetamol Formulations

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 13, 2012
Registry last updated
Dec 10, 2012

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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