The present study was a randomized, open-label, two-period, two-sequence, cross-over study, conducted to find out whether the etoricoxib 120 mg film-coated tablet produced by PT Dexa Medica (test drug) was bioequivalent to the reference drug (Arcoxia® Film-Coated Tablet 120 mg, PT. Schering-Plough Indonesia Tbk), under fasting condition with a fourteen days wash-out period, involving 26 healthy adult male and female subjects.
This was a randomized, open-label, two-period, two-sequence, cross-over study under fasting condition with a fourteen days wash-out period, involving 26 healthy adult male and female subjects. The participating subjects had an overnight fast and in the next morning were given orally either one film-coated tablet of the test drug or one film-coated tablet of the reference drug with 200 mL of water. Blood samples were drawn immediately before taking the drug (baseline), and at 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, and 72 hours after drug administration, analysed for plasma concentrations of etoricoxib and used to evaluate the pharmacokinetics parameters of the single dose administration. After a fourteen-day washout period, the procedure was repeated using the alternate drug. The plasma concentrations of etoricoxib were determined by using a high pressure liquid chromatography with ultraviolet detection (HPLC-UV) method.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
26
One tablet of the Test drug was given orally (swallowed with 200 mL of water, without chewing), after an overnight fast, and after fasting (pre-dose) blood-sampling.
One tablet of the Reference drug was given orally (swallowed with 200 mL of water, without chewing), after an overnight fast, and after fasting (pre-dose) blood-sampling.
PT Equilab International
Jakarta, Indonesia
AUC(0-t)
The area under plasma concentration-time curve from time zero to last observed concentration truncated at 72-hour (AUC0-72h)
Time frame: 72 hours
Cmax
Maximum plasma concentration
Time frame: 72 hours
Tmax
Time to maximum plasma concentration
Time frame: 72 hours
T1/2
The terminal half-life
Time frame: 72 hours
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