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| Name | Class |
|---|---|
| Severance Hospital | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD-841 A-1(=leuprorelin acetate 3.75mg) | Experimental | Investigational drug(=CKD-841 A-1) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once. |
|
| CKD-841 A-1(=leuprorelin acetate 1.88mg) | Experimental | Investigational drug(=CKD-841 A-1) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once. |
|
| CKD-841 D(=leuprorelin acetate 2.92mg) | Experimental | Investigational drug(=CKD-841 D) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once. |
|
| Leuplin Inj.(=leuprorelin acetate 3.75mg) | Active Comparator | Investigational drug(=Leuplin Inj.)is prescribed single injection dose by subcutaneous to 8 of randomized subjects once. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-841 A-1 3.75mg | Drug | Single injection, subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK(Cmax) | Cmax(Maximum concentration of drug in plasma) of Leuprorelin | 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 | 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 | 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 | From before injection to up to 1008 hours post injection |
| PK(CL/F) | CL/F(Apparent Clearance) of Leuprorelin | From before injection to up to 1008 hours post injection |
| PK(Vd/F) | Vd/F(Apparent Volume of Distribution) of Leuprorelin | From before injection to up to 1008 hours post injection |
| PK(Tmax) | Tmax(Time to Cmax/Time to Emax) of Leuprorelin | From before injection to up to 1008 hours post injection |
| PK(t1/2) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment by evaluating adverse events(AEs). | Assessment of the safety of subjects by evaluating adverse events(AEs). | From day1 to day 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Soo Park, Ph.D | Contact | 82-2-2228-0401 | minspark@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Min Soo Park, Ph.D | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | Yonsei-ro, Seodaemun-gu 50-1 | 03722 | South Korea |
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| ID | Term |
|---|---|
| D011629 | Puberty, Precocious |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| CKD-841 A-1 1.88mg | Drug | Single injection, subcutaneous injection |
|
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| CKD-841 D 2.92mg | Drug | Single injection, subcutaneous injection |
|
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| Leuplin Inj. 3.75 mg | Drug | Single injection, subcutaneous injection |
|
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t1/2(Terminal elimination half-life) of Leuprorelin |
| From before injection to up to 1008 hours post 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. | 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. | 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. | 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. | 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. | 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. | 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. | From before injection to up to 1008 hours post injection |