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| Name | Class |
|---|---|
| Severance Hospital | OTHER |
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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 Leuplinâ“¡ Inj. 3.75mg after subcutaneous injection in postmenopausal female is the purpose of this trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leuplinâ“¡Inj | Active Comparator | Leuplinâ“¡Inj(=leuprorelin acetate 3.75mg) |
|
| CKD-841 | Experimental | CKD-841(=leuprorelin acetate 3.75mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leuplinâ“¡Inj | Drug | Investigational drug(=Leuplinâ“¡Inj)is prescribed single injection dose by subcutaneous to 6 of randomized subjects once. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of Leuprorelin | Peak Plasma Concentration (Cmax) in ng/mL | 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 | 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 | 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 | 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 | 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 | From before injection to up to 1008 hours post injection |
| Follicular Stimulating Hormone(FSH) of Leuprorelin |
| 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 | 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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| CKD-841 | Drug | Investigational drug(=CDK-841) is prescribed single injection dose by subcutaneous to 6 of randomized subjects once. |
|
Follicular Stimulating Hormone(FSH) in IU/L |
| From before injection to up to 1008 hours post injection |
| Estradiol of Leuprorelin | Estradiol in pg/ml | From before injection to up to 1008 hours post injection |