Early Puberty
Conditions
Keywords
CKD-841, Postmenopausal, Leuplin
Brief summary
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
Detailed description
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
Interventions
DRUGCKD-841 A-1 3.75mg
Single injection, subcutaneous injection
DRUGCKD-841 A-1 1.88mg
Single injection, subcutaneous injection
DRUGCKD-841 D 2.92mg
Single injection, subcutaneous injection
DRUGLeuplin Inj. 3.75 mg
Single injection, subcutaneous injection
Sponsors
Severance Hospital
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy menopausal female * β-hCG is negative at screening and before administration of investigational drug * Infertility by sterilization operation before 5 months from screening excluding ovarian cancer, uterine cancer etc. * Bwt ≥ 50Kg and Body Mass Index (BMI) ≥ 18.5 and \< 28.0
Exclusion criteria
* History or current condition of disease related to Hepato-biliary system, renal system, nervous system, mental illness, immune system, respiratory system, endocrine system, hemato-oncology, circulatory system, musculoskeletal system or except for that, significant clinical disease * Uncontrolled diabetes mellitus in the last three months * Pregnancy or breast feeding * History of taking medicine such as Leuprorelin acetate or similar affiliation drug within 12 weeks before administration of investigational drug * Has hypersensitivity to the active ingredient or excipients or same affiliation drug of the investigational drug, hypersensitivity of a medicine contained gelatin especially
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PD(Emin) | From before injection to up to 1008 hours post injection | 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. |
| PK(Cmax) | From before injection to up to 1008 hours post injection | Cmax(Maximum concentration of drug in plasma) of Leuprorelin |
| PK(AUClast) | From before injection to up to 1008 hours post injection | AUClast(Area under the plasma drug concentration-time curve to last measurement) of Leuprorelin |
| PK(AUCinf) | From before injection to up to 1008 hours post injection | AUCinf(Area under the plasma drug concentration-time curve extrapolated to infinity) of Leuprorelin |
| PK(AUC7-t) | From before injection to up to 1008 hours post injection | AUC7-t(Area under the plasma drug concentration-time curve from 7 days to last measurement) of Leuprorelin |
| PK(CL/F) | From before injection to up to 1008 hours post injection | CL/F(Apparent Clearance) of Leuprorelin |
| PK(Vd/F) | From before injection to up to 1008 hours post injection | Vd/F(Apparent Volume of Distribution) of Leuprorelin |
| PK(Tmax) | From before injection to up to 1008 hours post injection | Tmax(Time to Cmax/Time to Emax) of Leuprorelin |
| PK(t1/2) | From before injection to up to 1008 hours post injection | t1/2(Terminal elimination half-life) of Leuprorelin |
| PD(AUEC0-42d below baseline) | From before injection to up to 1008 hours post injection | 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. |
| PD(AUEC0-28d below baseline) | From before injection to up to 1008 hours post injection | 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. |
| PD(Area under the response (% change from baseline) curve) | From before injection to up to 1008 hours post injection | 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. |
| PD(Tmax) | From before injection to up to 1008 hours post injection | 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. |
| PD(Tmin) | From before injection to up to 1008 hours post injection | 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. |
| PD(Emax) | From before injection to up to 1008 hours post injection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment by evaluating adverse events(AEs). | From day1 to day 56 | Assessment of the safety of subjects by evaluating adverse events(AEs). |
Countries
South Korea
Contacts
Primary ContactMin Soo Park, Ph.D
Outcome results
None listed