None listed
Conditions
Brief summary
The study hypothesis is that Maxigesic® intravenous infusion (intravenous acetaminophen 1000 mg + intravenous ibuprofen 300 mg/ 100 ml solution for infusion) is well tolerated over a treatment period of 5 days, and that the safety profile does not markedly change with extended exposure of 5 days.
Interventions
Maxigesic® intravenous infusion (acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion) administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes every 6 hours for a minimum of 48 hours (8 doses). The maximum duration of exposure will be at the discretion of the Investigator.
The administration of each dose will be documented in the Case Report Form (CRF) by a study nurse.
Sponsors
AFT Pharmaceuticals Ltd.
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
No
Inclusion criteria
Male or female greater than or equal to 18 years of age Is classified by the anesthesiologist as P1 to P2 in the American Society of Anesthesiologists (ASA) Physical Status Classification System Requires multiple doses of parenterally administered nonopioid analgesics over multiple days as a result of surgery (non-laparoscopic general, plastic or orthopedic surgery) Has an expected hospital stay greater than or equal to 48 hours Has a body weight greater than or equal to 45 kg
Exclusion criteria
1. Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, opioids, or any nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen); history of NSAID-induced bronchospasm (subjects with the triad of asthma, nasal polyps, and chronic rhinitis are at greater risk for bronchospasm and should be considered carefully); or hypersensitivity, allergy, or significant reaction to sulfa (including sulfonamide) medicines, ingredients of the study drug, or any other drugs used in the study including anesthetics and antibiotics that may be required on the day of surgery. 2. Has experienced any surgical complications or other issues that, in the opinion of the Investigator, could compromise the safety of the subject if he or she participates in the study or could confound the results of the study. 3. Has known or suspected history of alcoholism or drug abuse or misuse within 2 years of screening or evidence of tolerance or physical dependence before dosing with study drug. 4. Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease or any other condition that, in the opinion of the Investigator, could compromise the subject’s welfare, ability to communicate with the study staff, or otherwise contraindicate study participation. 5. Has a history or current diagnosis of a significant psychiatric disorder that, in the opinion of the Investigator, would affect the subject’s ability to comply with the study requirements. 6. Has tested positive either on the urine drug screen or on the alcohol breathalyzer test. Subjects who test positive and can produce a prescription for the medication from their physician may be considered for study enrolment at the discretion of the Investigator. 7. Has a history of a clinically significant (Investigator opinion) gastrointestinal (GI) event within 6 months before screening or has any history of peptic or gastric ulcers or GI bleeding. 8. Has a surgical or medical condition of the GI or renal system that might significantly alter the absorption, distribution, or excretion of any drug substance. 9. Is considered by the Investigator, for any reason (including, but not limited to, the risks described as precautions, warnings, and contraindications in the current version of the Investigator’s Brochure (IB) for Maxigesic® IV to be an unsuitable candidate to receive the study drug. 10. Is receiving systemic chemotherapy, has an active malignancy of any type, or has been diagnosed with cancer within 5 years before Screening (excluding treated squamous or basal cell carcinoma of the skin). 11. Is currently receiving anticoagulants (e.g. heparin or warfarin). 12. Has received a course of systemic corticosteroids (either oral or parenteral) within 3 months before screening (inhaled nasal steroids and regional/limited area application of topical corticosteroids (Investigator discretion) are allowed). 13. Has a history of chronic use (defined as daily use for > 2 weeks) of NSAIDs, opiates, or glucocorticoids (except inhaled nasal steroids and regional/limited topical corticosteroids), for any condition within 6 months before study drug administration. Aspirin at a daily dose of less than or equal to 325 mg is allowed for cardiovascular prophylaxis if the subject has been on a stable dose regimen for greater than or equal to 30 days before screening and has not experienced any relevant medical problem. 14. Has a significant renal or hepatic disease, as indicated by clinical laboratory assessment (results of greater than or equal to 3 times the upper limit of normal [ULN] for any liver function test, including aspartate aminotransferase [AST], alanine aminotransferase [ALT], or creatinine greater than or equal to 1.5 times the ULN). 15. Has any clinically significant laboratory finding at screening that, in the opinion of the Investigator, contraindicates study participation. 16. Previously participated in another clinical study of Maxigesic® IV or received any investigational drug or device or investigational therapy within 30 days before Screening.
Outcome results
None listed