This is a single dose, open-label, randomised, two period, two-way cross-over, two stage bioequivalenve study with the aim to investigate the bioequivalence between a new formulation of ketoprofen 25 mg versus OKI 80 mg granules for oral solution (half sachet), after single dose administration in two consecutive periods to healthy voluteers under fed conditions.
The present bioequivalence phase I study has been designed to compare the bioavailability and the concentration-time profile of the new immediate release oral gel formulation of ketoprofen 25 mg with a marketed reference of ketoprofen lysine salt (KLS) as granules for oral solution (80 mg bipartite sachet, half sachet containing 40 mg of KLS, corresponding to 25 mg as ketoprofen), when administered in fed conditions to healthy male and female subjects. The study has been designed under fed conditions since the leaflet of the reference. A two-stage design has been selected for the present study considering the margin of uncertainty existing over the sample size estimate in order to accomplish the primary study objectives in terms of ketoprofen rate (Cmax) and extent (AUC0-t) of absorption of the two formulations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
36
A single oral dose of test product - ketoprofen 25 mg/5 ml oral gel stick pack - will be administered to healthy male and female volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations.
A single oral dose of reference product as a single dose of half of a bipartite sachet of OKi® 80 mg granules for oral solution will be administered to healthy male and female volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations.
CROSS Research S.A., Phase I Unit,
Arzo, Switzerland
Maximum plasma concentration of ketoprofen
to evaluate the rate (Cmax) of absorption of ketoprofen after single oral dose of test and reference.
Time frame: pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
Area under the concentration-time curve 0-t
to evaluate the extent (AUC0-t) of absorption after single oral dose of test and reference
Time frame: pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
Time to achieve Cmax
to evaluate Tmax after single oral dose of test and reference products
Time frame: pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
t1/2
to evaluate Half-life after single oral dose of test and reference products
Time frame: pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
tlag after single oral dose of test and reference products
to evaluate Lag-time observed from the dosing time point prior to that of the first measurable plasma concentration
Time frame: pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
AUC0-∞ and residual area of ketoprofen derived from plasma concentrations after single oral dose of test and reference products;
Area under the concentration-time curve extrapolated to infinity
Time frame: pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
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Treatment-Emergent Adverse Events
to evaluate number of TEAEs and percentage of subjects with TEAEs
Time frame: through study completion, an average two weeks
Blood pressure measurement
to assess diastolic and systolic blood pressure after 5 min of rest (sitting position).
Time frame: pre-dose, 45 minutes and 24 hours post dose
Heart rate
to assess heart rate after 5 min of rest (sitting position).
Time frame: pre-dose, 45 minutes and 24 hours post dose