PIANO: Pharmacokinetics of Ibuprofen and Acetaminophen in Normal and Overweight adults

Not Applicable

Completed

• Conditions: Pharmacokinetics of analgesics in obesity; Anaesthesiology - Pain management

• Registration Number: ACTRN12610000273088
• Lead Sponsor: niversity of South Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Participant is >18 years of age at the time of informed consent.
2. Participant in a male or non-pregnant (as evidenced by a negative urine pregnancy test in women of child-bearing potential), non-lactating female.
3. Particpant is a non-smoker.
4. Participant has previously received 2 or more doses each of paracetamol and ibuprofen with no significant adverse events.
5. Participant is aware of the study procedures and the risks involved, and voluntarily agrees to participate by providing written informed consent.
Participants shall be classified as normal weight (18.5-25mg/m2), overweight (25-30kg/m2) or obese (>30kg/m2) based on BMI.

Exclusion Criteria

1. Participant has a history of allergy and/or sensitivity to paracetamol or non-steroidal anti-inflammatory drugs.
2. Participant has a medical condition or has received treatment with a pharmacologic agent for which administration of paracetamol and/or ibuprofen is contraindicated as outlined in the current product information.
3. Participant has a history or current evidence of any condition, therapy or laboratory abnormality that, in the opinion of the medical officer, might affect the results of the study or may not be in the best interest of the participant to take part.
4. Participant has received treatment with paracetamol or ibuprofen containing products within 24 hours of study treatment administration.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the impact of varying body mass index on paracetamol, ibuprofen and metabolite pharmacokinetics in adults.[Screening: within 1 month prior to treatment administration.<br>Study Visit: Subjects are confined to the study unit from prior to dosing until 8 hours after treatment administration. Fingerprick blood and saliva samples for pharmacokinetic analysis will be collected prior to dosing, 0.5, 1, 1.5, 2, 3, 4, 6 & 8 hours after treatment administration.]

Secondary Outcome Measures

Name	Time	Method
To determine the relationship between venous blood plasma paracetamol, ibuprofen and metabolite concentrations and those obtained from saliva and fingerprick blood samples.[Venous blood, saliva and fingerprick blood samples will be collected at 0.5, 2 & 4 hours after treatment administration.]