The main purpose of this study was to evaluate the pharmacokinetic (PK) profile of ibuprofen after oral administration of a single dose of MOMENT ACT ANALGESIC granules to healthy male and female subjects, under fasting conditions.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
24
ibuprofen 400 mg single dose oral solution
CROSS Research S.A., Phase I Unit, Via F.A. Giorgioli 14 Phone: Fax: +41.91.63.00.511 Email:
Arzo, Switzerland
Maximum plasma concentration (Cmax) of ibuprofen
Time frame: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose
Area under the plasma concentration versus time curve (AUC) of ibuprofen
Time frame: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose
Time to Cmax (Tmax) of ibuprofen
Time frame: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose
Apparent terminal elimination rate constant (λz) of ibuprofen
Time frame: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose
Apparent terminal elimination half-life (t1/2,z) of ibuprofen
Time frame: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose
Lag-time from the dosing time point prior to the first measurable plasma concentration (tlag) of ibuprofen
Time frame: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose
Time to the first ibuprofen plasma concentration of 5 ug/mL (ton5)
Time frame: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose
Time to the first ibuprofen plasma concentration of 10 ug/mL (ton10)
Time frame: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose
Occurrence of adverse effects
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Time frame: up to 24 hours after administration