The purpose of this study is to compare the pharmacokinetics and safety of NVP-2102 and NVP-2102-R.
Evaluate the pharmacokinetics and safety of NVP-2102 compared to NVP-2102-R
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Tablet formulation for oral administration, single dose of NVP-2102 at Day 1
Tablet formulation for oral administration, single dose of NVP-2102-R at Day 1
H Plus Yangji Hospital
Seoul, Nambusunhwan-ro, South Korea
Evaluation of Area under the plasma drug concentration-time curve(AUCt)
Pharmacokinetics parameter derived from plasma
Time frame: 0 ~ 72 hours
Evaluation of Maximum observed plasma concentration(Cmax)
Pharmacokinetics parameter derived from plasma
Time frame: 0 ~ 72 hours
Evaluation of Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞)
Pharmacokinetics parameter derived from plasma
Time frame: 0 ~ 72 hours
Evaluation of AUCt/AUC∞
Pharmacokinetics parameter derived from plasma
Time frame: 0 ~ 72 hours
Evaluation of Time of peak concentration(Tmax)
Pharmacokinetics parameter derived from plasma
Time frame: 0 ~ 72 hours
Evaluation of Terminal phase of Half-life(t1/2)
Pharmacokinetics parameter derived from plasma
Time frame: 0 ~ 72 hours
Evaluation of total clearance of the drug from plasma after oral administration(CL/F)
Pharmacokinetics parameter derived from plasma
Time frame: 0 ~ 72 hours
Evaluation of volume of distribution after non-intravenous administration(Vz/F)
Pharmacokinetics parameter derived from plasma
Time frame: 0 ~ 72 hours
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