This study is an open-label, randomized, fasted, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tofacitinib Tablet" and Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in healthy volunteers
To healthy subjects of forty (40), following treatments are administered dosing in each period and wash-out period is a minimum of 1 week. Reference drug: XELJANZ 5Mg Tablet / Test drug: Chong Kun Dang Tofacitinib Tablet Pharmacokinetic blood samples are collected up to 12hrs. The pharmacokinetic characteristics and safety are assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
XELJANZ 5Mg Tablet 1T single oral administration under fasting
Chong Kun Dang Tofacitinib Tablet 1T single oral administration under fasting
Bestian Hospital
Osŏng, South Korea
AUCt of Chong Kun Dang Tofacitinib Tablet and XELJANZ 5Mg Tablet
Area under the Chong Kun Dang Tofacitinib Tablet / XELJANZ 5Mg Tablet concentration in blood-time curve from zero to final
Time frame: Pre-dose (0 hour), post-dose 0.083, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Cmax of Chong Kun Dang Tofacitinib Tablet and XELJANZ 5Mg Tablet
The maximum Chong Kun Dang Tofacitinib Tablet / XELJANZ 5Mg Tablet concentration in blood sampling time t
Time frame: Pre-dose (0 hour), post-dose 0.083, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
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