Pharmacokinetic study of acetaminophen and ibuprofen, oral formulations, in healthy volunteers under fed conditions

Phase 1

Completed

• Conditions: Pain relief; Anaesthesiology - Pain management

• Registration Number: ACTRN12616000317493
• Lead Sponsor: AFT Pharmaceuticals Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-10
• 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 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.
All subjects 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

Pregnancy, nursing, drug abuse, smoking>10 cigarettes per day, excess alcohol intake, prescription drugs within 14 days of the study, participating in another trial within 80 days, clinically significant abnormal laboratory tests

Study & Design

• Study Type: Interventional
• Study Design: Not specified