This is an open-label, randomised, 3-period, 3-sequence single-dose crossover study to determine the comparative pharmacokinetic profile of the Test Investigational Medicinal Product (IMP) Ibuprofen 200 mg soft gel capsule (lipid formulation) with that from the reference products Nurofen® 200 mg tablet and ibuprofen 200 mg soft gel capsule following single dose administration in healthy male and female subjects. The study comprises of a pre-study screen (within 14 days of the first dose), followed by 3 Treatment Periods (1, 2 and 3) and a post study follow up (3 - 7 days after the last dose). Each Treatment Period is of 1 day in duration, from the afternoon before dosing (Day -1) until 12 hours (h) post-dose (Evening of Day 1). Study drug is administered on the morning of Day 1 following an overnight fast. PK samples will be collected pre-dose and up to 12 h post-dose (x15 samples) for the measurement of ibuprofen. Safety is evaluated at specified times throughout the study. There is at least 48 h between dose administrations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Simbec Research Limited
Merthyr Tydfil, United Kingdom
Pharmacokinetics
Maximum plasma concentration (Cmax), time to Cmax (tmax), elimination rate constant (λz), terminal half-life (t1/2), area under the concentration-time curve (AUC) from time of dosing to last measurable concentration (AUC0-t), partial area under plasma concentration time curve at the following nominal blood sampling time points 15min, 30min, 45min, 1h, 1.20h, 1.40h and 2h (AU0-n), AUC extrapolated to infinity (AUC0-∞), plasma clearance (CL/F), MRT (mean residence time) and AUC% extrapolated (residual area).
Time frame: PK samples are taken up to 12 hours of each study period.
Safety
AEs, vital signs (sitting blood pressure and pulse), ECG (heart rate, PR interval, QRS width, QT interval and QTcB interval) and laboratory (haematology, biochemistry and urinalysis) data.
Time frame: participants will be followed for the duration of stay, an expected average of 3 weeks
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