ACTRN12616000316404CompletedPhase 1
Single-centre, randomized, single dose, three-period cross-over open-label dose-normalized pharmacokinetic study of a fixed dose oral combination of acetaminophen and ibuprofen versus acetaminophen oral formulation and ibuprofen oral formulation, in healthy volunteers, fasting conditions
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AFT Pharmaceuticals Ltd.
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (—)
- Sex
- All
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, alcohol intake, prescription drugs within 14 days of the study, participating in another trial within 80 days, clinically significant abnormal lab tests.
Investigators
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