Postmenopausal Disorder
Conditions
Keywords
CKD-841, Leuplin, Postmenopausal
Brief summary
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.
Detailed description
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.
Interventions
DRUGLeuplinⓡInj
Investigational drug(=LeuplinⓡInj)is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.
DRUGCKD-841
Investigational drug(=CDK-841) is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.
Sponsors
Severance Hospital
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
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 \< 25
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 * 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 * Has abnormal function of liver and kidney at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estradiol of Leuprorelin | From before injection to up to 1008 hours post injection | Estradiol in pg/ml |
| Peak Plasma Concentration (Cmax) of Leuprorelin | From before injection to up to 1008 hours post injection | Peak Plasma Concentration (Cmax) in ng/mL |
| Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) of Leuprorelin | From before injection to up to 1008 hours post injection | Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) in ng•hr/mL |
| Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) of Leuprorelin | From before injection to up to 1008 hours post injection | Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) in ng•hr/mL |
| Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) of Leuprorelin | 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) in ng•hr/mL |
| The time -to-maximal serum or plasma concentrations (Tmax) of Leuprorelin | From before injection to up to 1008 hours post injection | The time -to-maximal serum or plasma concentrations (Tmax) in hr |
| Terminal half-life (t1/2) Luteinizing Hormone(LH) of Leuprorelin | From before injection to up to 1008 hours post injection | Terminal half-life (t1/2) Luteinizing Hormone(LH) in IU/L |
| Follicular Stimulating Hormone(FSH) of Leuprorelin | From before injection to up to 1008 hours post injection | Follicular Stimulating Hormone(FSH) in IU/L |
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
Outcome results
None listed