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

NCT01551836 | Completed Phase 1

• 1 other identifier: E3870651
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer

Keywords

pharmacokinetics; paracetamol

Outcome Measures

Primary Outcomes (1)

• Mean time to therapeutic levels of plasma concentration

  within a single day

Secondary Outcomes (1)

• Mean plasma concentrations

  within a single day

Study Arms (2)

Paracetamol formulation 1

OTHER

Higher dose level of marketed paracetamol (compared to the other dosage arm)

Drug: Paracetamol formulation 1

Paracetamol formulation 2

OTHER

Lower paracetamol concentrations

Drug: Paracetamol formulation 2

Interventions

Paracetamol formulation 1 DRUG

formulation 1

Paracetamol formulation 1

Paracetamol formulation 2 DRUG

Formulation 2

Paracetamol formulation 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Disease
• Current liver impairment, renal impairment, history of or active gastrointestinal ulcers, uncontrolled hypertension, haemophilia or other bleeding disorders.
• 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).
• 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
• 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.
• 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).
• 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
• Positive urine screen for drugs of abuse at screening and/or Day-1.
• Positive alcohol breath test on Day-1.
• Smoking
• Smoking more than five cigarettes a day.
• Prior (within 7 days of dosing on Day 1) or current use of any other nicotine containing products, other than cigarettes/pipes/cigars.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Belfast, Northern Ireland, BT9 6AD, United Kingdom

Location

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: March 13, 2012
• Study Start: June 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 13, 2012

Record last verified: 2012-03

Locations

GB (1)