At What Time Therapeutic Plasma Concentrations of Paracetamol Are Achieved in Two Marketed Formulations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01551836
First received: June 23, 2011
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

This will be a single centre, open label, randomised, two-way crossover study in healthy volunteers under semi-fed conditions. Two formulations of paracetamol, are being tested in this study to establish at what time point a therapeutic concentration of paracetamol in the blood is reached. Subjects will attend a screening visit to check if they are eligible for study participation then within 15 days they will check-in to the unit for a stay of approximately 48 hours (hrs). They will be given a single dose of one of the preparations on the first day and then the other preparation on the next day. Regular blood samples will be taken along with other assessments for safety.


Condition Intervention Phase
Healthy Volunteer
Drug: Paracetamol formulation 1
Drug: Paracetamol formulation 2
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: A Randomised, Two Way Crossover Study to Determine the Time at Which Therapeutic Plasma Concentrations of Paracetamol Are Achieved in Two Marketed Formulations

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean time to therapeutic levels of plasma concentration [ Time Frame: within a single day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean plasma concentrations [ Time Frame: within a single day ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: June 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Paracetamol formulation 1
Higher dose level of marketed paracetamol (compared to the other dosage arm)
Drug: Paracetamol formulation 1
formulation 1
Paracetamol formulation 2
Lower paracetamol concentrations
Drug: Paracetamol formulation 2
Formulation 2

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males in good general heatlh and Body Mass Index between 19-28 kg/m2

Exclusion Criteria:

  • Disease

    1. Current liver impairment, renal impairment, history of or active gastrointestinal ulcers, uncontrolled hypertension, haemophilia or other bleeding disorders.
    2. Current or recurrent disease, within 12 months of the screening, that could affect the action, absorption or disposition of the study formulations or clinical or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure).
    3. Current or relevant previous history, within 12 months of the screening visit, of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study treatments or procedures.
  • Medications

    1. Current or regular use at screening of any prescription, herbal or Over the Counter (OTC) medication including paracetamol, aspirin, metaclopramide, domperidone, cholestyramine, angiotensin -converting enzyme (ACE) inhibitors, acetazolamide, anticonvulsants, diuretics, methotrexate, non-steroidal anti-inflammatory drugs (NSAIDs) and oral hypoglycemics within the past 48 hrs and monoamine oxidase inhibitors, tricyclic antidepressants, beta blockers and anticoagulants such as warfarin and heparin within the past 2 weeks.
    2. Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to the screening visit (some examples of inducers: barbiturates, theophylline; inhibitors: cimetidine, erythromycin).
    3. Subjects for whom the use of any of the study drugs is contraindicated.
  • Virology Screening Positive screening for serum Hepatitis B surface antigen, Hepatitis C antibodies or human immunodeficiency virus (HIV).
  • Drug Screen

    1. Positive urine screen for drugs of abuse at screening and/or Day-1.
    2. Positive alcohol breath test on Day-1.
  • Smoking

    1. Smoking more than five cigarettes a day.
    2. Prior (within 7 days of dosing on Day 1) or current use of any other nicotine containing products, other than cigarettes/pipes/cigars.
  • Blood donation Has donated blood or plasma or any other blood product within 3 months of the screening visit. Subjects for whom participation in this study would result in having donated more than 1500 ml of blood within the previous 12 months.
  • Nutrition

    1. Is a vegetarian or is under a sodium restricted diet.
    2. Has consumed poppy seed containing foods within 3 days prior to the screening visit and admission on Day -1.
    3. Has consumed food and beverages containing grapefruit, Seville oranges or marmalade within 24 hrs prior to admission on Day -1.
    4. Has consumed caffeine containing drinks or food (e.g. tea, coffee, chocolate and cola) 24 hrs prior to admission on Day -1.
    5. Has consumed alcohol 36 hrs prior to admission on Day -1.
  • Has undertaken any unusually strenuous physical activity 24 hrs prior to the screening visit or check-in on Day 1.
  • Weight Weight below 50 kg.
  • Haemoglobin Subjects with haemoglobin level below 12.0 gram /decilitre (dl).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551836

Locations
United Kingdom
GSK Investigational Site
Belfast, N Ireland, United Kingdom, BT9 6AD
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01551836     History of Changes
Other Study ID Numbers: E3870651
Study First Received: June 23, 2011
Last Updated: March 8, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
pharmacokinetics
paracetamol

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on August 18, 2014