None listed
Conditions
Brief summary
Whilst paracetamol and ibuprofen are relatively safe and effective medications, high doses have been associated with potentially fatal liver damage or gastrointestinal problems whilst administration of low doses can result in inadequate treatment of pain and/or fever. This study is being conducted to investigate how increased body size impacts on how the body handles these medications. It is proposed that the results of this study will be used to guide dosing strategies for patients who are overweight or obese.
Interventions
Each subject will recevie a single oral dose of 1g paracetamol and 400mg ibuprofen on a single occasion. Treatment will be administered with 500mL of water under fasting conditions.
Sponsors
University of South Australia
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Outcome results
None listed