A randomized, single-blinded, parallel design phase I clinical trial to investigate the safety and pharmacokinetics/pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. after subcutaneous injection in postmenopausal female
To investigate the safety and pharmacokinetics/pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. 3.75 mg after subcutaneous injection in postmenopausal female
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
Single injection, subcutaneous injection
Single injection, subcutaneous injection
Single injection, subcutaneous injection
Severance Hospital
Seoul, Yonsei-ro, Seodaemun-gu 50-1, South Korea
PK(Cmax)
Cmax(Maximum concentration of drug in plasma) of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
PK(AUClast)
AUClast(Area under the plasma drug concentration-time curve to last measurement) of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
PK(AUCinf)
AUCinf(Area under the plasma drug concentration-time curve extrapolated to infinity) of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
PK(AUC7-t)
AUC7-t(Area under the plasma drug concentration-time curve from 7 days to last measurement) of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
PK(CL/F)
CL/F(Apparent Clearance) of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
PK(Vd/F)
Vd/F(Apparent Volume of Distribution) of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
PK(Tmax)
Tmax(Time to Cmax/Time to Emax) of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
PK(t1/2)
t1/2(Terminal elimination half-life) of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
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Single injection, subcutaneous injection
PD(AUEC0-42d below baseline)
AUEC0-42d below baseline((AUEC that is below the baseline from 0 h to 42 days)) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
Time frame: From before injection to up to 1008 hours post injection
PD(AUEC0-28d below baseline)
AUEC0-28d below baseline(AUEC that is below the baseline from 0 h to 28 days) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
Time frame: From before injection to up to 1008 hours post injection
PD(Area under the response (% change from baseline) curve)
AUEC(Area under the response (% change from baseline) curve) above baseline of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
Time frame: From before injection to up to 1008 hours post injection
PD(Tmax)
Tmax(Time to Cmax/Time to Emax) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
Time frame: From before injection to up to 1008 hours post injection
PD(Tmin)
Tmin(Time to Emin) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
Time frame: From before injection to up to 1008 hours post injection
PD(Emax)
Emax(Maximum % change from baseline of LH/FSH/Estradiol) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
Time frame: From before injection to up to 1008 hours post injection
PD(Emin)
Emin(Minimum % change from baseline of LH/FSH/Estradiol) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
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