Phase I Pharmacokinetic study evaluating the pharmacokinetic profile of a fixed dose combination product (1000 mg paracetamol + 300 mg ibuprofen) under fasting and fed conditions

Phase 1

Completed

• Conditions: Pharmacokinetic study; Other - Research that is not of generic health relevance and not applicable to specific health categories listed above

• Registration Number: ACTRN12613001151729
• Lead Sponsor: AFT Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Healthy volunteers.
Participants must not have taken any prescription medications for at least 14 days or over-the-counter medications for at least 7 days before the start of each study phase, with the exception of oral contraceptives and the study medication.

Exclusion Criteria

Pregnancy, nursing, drug abuse, smoking > 10 cigarettes per day, excess alcohol intake, Rx drugs within 14 days of the study, participating in another trial within 80 days, clinically significant abnormal lab tests, have any history of allergy or hypersensitivity to ibuprofen, aspirin, paracetamol or other NSAID

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- To define the pharmacokinetic parameters of 1000 mg paracetamol and 300 mg ibuprofen each one alone, or in combination as 2 tablets including:Cmax, Tmax, T1/2, AUC(0-t), AUC(0-inf)<br> [Single dose study measuring plasma concentrations over 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 6, 8, 10 and 12 hours after study drug administration ];To compare the AUC(0-t) and AUC(0-inf) and Cmax values following fed and fasting administration of 2 tablets of a fixed dose combination of paracetamol 1000 mg + 300 mg ibuprofen to provide an estimate of food effect[Single dose study measuring plasma concentrations over 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 6, 8, 10 and 12 hours after study drug administration ]