This study aims to evaluate the pharmacokinetic interaction between HL237 and tacrolimus in healthy male subjects.
To evaluate the pharmacokinetic interaction by comparing of pharmacokinetic parameters when administered HL237(or tacrolimus) between with tacrolimus(or HL237) and without tacrolimus(or HL237).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
24
HL237 400mg will be administered orally twice a day.
tacrolimus 5mg will be administered orally once a day.
The Korea Univertisy Anam Hospital
Seoul, South Korea
Peak plasma concentration at steady state(Cmax,ss) of HL237
Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237
Time frame: 0(before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour(after dosing) on day 21 and day 22
Area under the plasma concentration versus time curve during a dosage interval(AUCτ) of HL237
Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237
Time frame: 0(before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour(after dosing) on day 21 and day 22
Peak whole-blood concentration(Cmax) of tacrolimus
Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237
Time frame: 0(before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hour(after dosing) on day 1 and day 22
Area under the whole-blood concentration versus time curve from time zero to time of last measurable concentration(AUClast) of tacrolimus
Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237
Time frame: 0(before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hour(after dosing) on day 1 and day 22
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