A randomized, open-label, single dose, parallel design phase I clinical trial to investigate the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplin Inj. 3.75mg after subcutaneous injection in postmenopausal female.
To investigate the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplinⓡ Inj. 3.75mg after subcutaneous injection in postmenopausal female is the purpose of this trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Investigational drug(=LeuplinⓡInj)is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.
Investigational drug(=CDK-841) is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.
Severance Hospital
Seoul, Yonsei-ro, Seodaemun-gu 50-1, South Korea
Peak Plasma Concentration (Cmax) of Leuprorelin
Peak Plasma Concentration (Cmax) in ng/mL
Time frame: From before injection to up to 1008 hours post injection
Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) of Leuprorelin
Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) in ng•hr/mL
Time frame: From before injection to up to 1008 hours post injection
Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) of Leuprorelin
Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) in ng•hr/mL
Time frame: From before injection to up to 1008 hours post injection
Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) of Leuprorelin
Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) in ng•hr/mL
Time frame: From before injection to up to 1008 hours post injection
The time -to-maximal serum or plasma concentrations (Tmax) of Leuprorelin
The time -to-maximal serum or plasma concentrations (Tmax) in hr
Time frame: From before injection to up to 1008 hours post injection
Terminal half-life (t1/2) Luteinizing Hormone(LH) of Leuprorelin
Terminal half-life (t1/2) Luteinizing Hormone(LH) in IU/L
Time frame: From before injection to up to 1008 hours post injection
Follicular Stimulating Hormone(FSH) of Leuprorelin
Follicular Stimulating Hormone(FSH) in IU/L
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Time frame: From before injection to up to 1008 hours post injection
Estradiol of Leuprorelin
Estradiol in pg/ml
Time frame: From before injection to up to 1008 hours post injection
Safety Assessment by evaluating adverse events(AEs).
Assessment of the safety of subjects by evaluating adverse events(AEs).
Time frame: From day1 to day 56