Pharmacokinetic study of acetaminophen and ibuprofen, solution for infusion and the oral tablet of acetaminophen and ibuprofen in healthy volunteers

Phase 1

Completed

• Conditions: Analgesia; Anaesthesiology - Pain management

• Registration Number: ACTRN12615001208594
• Lead Sponsor: AFT Pharmaceuticals Ltd.

Brief Summary

This study confirmed that for the fixed dose combination Maxigesic IV (acetaminophen 1000mg + ibuprofen 300mg/100mL) the maximum blood levels and the time profile of the drugs in the body is similar to either drug by itself (acetaminophen 1000mg /100mL or ibuprofen 300mg/100mL) when administered by intravenous infusion. Overall exposure to acetaminophen and ibuprofen was similar between Maxigesic IV and Maxigesic 325 tablets (Acetaminophen 975mg + ibuprofen 292.5mg). However, as expected the maximum blood level of both drugs was higher when administered by intravenous infusion compared to oral administration.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-06
• Study Completion: 2016-05-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Healthy volunteers, males and females aged 18 to 50 years of age. Females must be sterile or using adequate contraception. Participants must not have taken any medications for at least 14 days before the start of each study phase, with the exception of oral contraceptives.
All volunteers must be deemed healthy on the basis of a medical history, physical exam (including vital signs and ECG recording), urinalysis, and blood biochemical and haematological examinations.

Exclusion Criteria

1..Women who are pregnant or nursing.
2. Women 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.
3. Women of childbearing potential who are unwilling to undergo a urine pregnancy test.
4. Have an alcohol intake in excess of 14 units per week for females and 21 units per week for males.
5. Have a history of drug abuse or positive test results for drug abuse.
6. Is a current smoker.
7. Have used prescription drugs (not including oral contraceptives) within 14 days prior to study drug administration or have used over-the-counter drugs herbal products or vitamins within 7 days prior to study drug administration, unless the Principal Investigator and Sponsor agree that the product taken will not impact on study conduct, results or participant safety.
8. Currently, or in last 30 days, participating in a clinical trial involving another study drug
9. Have donated blood or blood products within 30 days prior to study drug administration
10. Have a clinically significant abnormal laboratory test (as determined by the Principle Investigator)
11. 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
12. Have any history of allergy or hypersensitivity to ibuprofen, aspirin or other NSAID
13. Have any history of allergy or hypersensitivity to acetaminophen
14. Have severe known haemopoetic, renal or hepatic disease, immunosuppression
15. Have a history of gastric ulceration, indigestion, stomach pain or GI bleeding or bleeding disorders
16. Currently suffering from dehydration through diarrhoea and/or vomiting
17. Have a history of severe asthma defined as previous steroid treatment or hospital admission within the last 5 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified