None listed
Conditions
Brief summary
This study is designed as a phase 1 study to evaluate and compare the pharmacokinetic parameters (Cmax, AUC0-t, AUC0-inf, Tmax, Kel and t1/2el) between test and reference products under fasting conditions
Interventions
Test Product: Maxigesic® Intravenous Infusion (Acetaminophen 1000 mg + Ibuprofen 300 mg in 100mL solution infusion).
Each intravenous study formulation will be administered as a single, intravenous dose, infused over 15 minutes into an intravenous cannula.
There will a washout period of at least 3 days from the completion of dosing in one period to the start of dosing in the next period.
Healthy volunteers will be fasted for at least 10 hours overnight before dosing and for 4 hours after dos
Test Product: Maxigesic® Intravenous Infusion (Acetaminophen 1000 mg + Ibuprofen 300 mg in 100mL solution infusion). Each intravenous study formulation will be administered as a single, intravenous dose, infused over 15 minutes into an intravenous cannula. There will a washout period of at least 3 days from the completion of dosing in one period to the start of dosing in the next period. Healthy volunteers will be fasted for at least 10 hours overnight before dosing and for 4 hours after dosing at the study site. Water will be restricted for 1 hour pre dose and 1 hour post dose. The test product will be administered under the site staff's supervision and the exact dosing time will be documented.
Sponsors
AFT Pharmaceuticals Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy male and female volunteers aged 18 to 50 years of age. Females must be sterile or using adequate contraception. Participants must not have taken any prescription medications for at least 14 days or over-the-counter medications and herbal remedies for at least 7 days before the start of each study phase and for the duration of the study, with the exception of oral contraceptives and the study medication.
Exclusion criteria
• Female who are pregnant or nursing (not applicable for male subjects). • Female of childbearing potential who are unwilling to take adequate contraceptive precautions, i.e., a hormonal contraceptive, an intrauterine device, double-barrier method, or abstinence. A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a partial or total hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral oophorectomy (not applicable for male subjects). • Female of childbearing potential who are unwilling to undergo a urine pregnancy test (not applicable for male subjects). • Have an alcohol intake in excess of 14 units per week for females and 21 units per week for males. • Have a history of drug abuse or positive test results for drug abuse during screening. • Unwilling to abstain from smoking throughout the whole duration of the study • Unable and refuse to abstain the used prescription drugs (not including oral contraceptives and the study medication) within 14 days prior to study drug administration or have used over-the-counter drugs or herbal products within 7 days prior to study drug administration and during the study. • Unable and refuse to abstain the use of vitamins for nutritional purposes within 2 days prior to study drug administration until the last study sample is collected in each period. • Unable and refuse to abstain to consume grapefruit containing foods or beverages within 7 days or caffeine containing foods or beverages within 24 hours prior to study drug administration until the last study sample is collected in each period. • Currently, or in last 80 days, participating in a clinical trial involving another study drug. • Have donated blood or blood products within 60 days prior to study drug administration. • Have a clinically significant abnormal laboratory test (as determined by the Principal Investigator), Hb, PCV and RBC indices (MCV, MCH and MCHC) tests which deviated outside the 5% of reference range or laboratory results of liver or kidney function tests (creatinine, urea and ALP will be accepted if below reference range, total protein and albumin accepted if above reference range) are outside the reference range. • Be on a special diet (for example is vegetarian). • Unable and refuse to abstain to engage in strenuous exercise within 24 hours prior to study drug administration until the last sample is collected in each study period. • Have at screening examination a pulse outside the normal range of (60-100 beat per minute) or a body temperature outside the normal range of (35.0-37.2 Degrees Celsius ) or a respiratory rate outside the normal range of (14-20 breath per minute) or a sitting blood pressure less than 100/60 mm Hg or more than or equal to 140/90 mm Hg. • Unable and refuse to abstain to consume any beverages or food containing alcohol for at least 24 hours prior to study drug administration until the last study sample is collected in each period. • Have a history of difficulties in swallowing or any gastrointestinal disease which could affect the drug absorption. • Suffering from any other diseases or condition which, in the opinion of the investigator, means that it would not be in the participant’s best interests to participate in this study. • Subject is a heavy smoker (more than 10 cigarettes per day). • Acute infection within one week preceding study drug administration. • Have any history of allergy or hypersensitivity to ibuprofen, aspirin or other NSAID. • Have any history of allergy or hypersensitivity to acetaminophen. • Have severe known haemopoetic, renal or hepatic disease, immunosuppression. • Have a history of gastric ulceration, indigestion, stomach pain or GI bleeding or bleeding disorders. • Currently suffering from dehydration through diarrhoea and/or vomiting. • Have a history of severe asthma defined as previous steroid treatment or hospital admission within the last 5 years. • Have a history of severe hypertension, ventricular tachycardia or other cardiac disease. • Have a history of long-standing insulin dependent diabetes mellitus.
Outcome results
None listed