The Safety and Pharmacokinetic/Pharmacodynamic Study of CKD-841 in Postmenopausal Female, Phase 1

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Early Puberty

Intervention / Treatment
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* Drug: CKD-841 A-1 3.75mg
* Drug: CKD-841 A-1 1.88mg
* Drug: CKD-841 D 2.92mg
* Drug: Leuplin Inj. 3.75 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD-841 A-1(=leuprorelin acetate 3.75mg)<br>Investigational drug(=CKD-841 A-1) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once. | Drug: CKD-841 A-1 3.75mg<br>* Single injection, subcutaneous injection<br>* Other names: CKD-841;|
| Experimental: CKD-841 A-1(=leuprorelin acetate 1.88mg)<br>Investigational drug(=CKD-841 A-1) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once. | Drug: CKD-841 A-1 1.88mg<br>* Single injection, subcutaneous injection<br>* Other names: CKD-841;|
| Experimental: CKD-841 D(=leuprorelin acetate 2.92mg)<br>Investigational drug(=CKD-841 D) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once. | Drug: CKD-841 D 2.92mg<br>* Single injection, subcutaneous injection<br>* Other names: CKD-841;|
| Active Comparator: Leuplin Inj.(=leuprorelin acetate 3.75mg)<br>Investigational drug(=Leuplin Inj.)is prescribed single injection dose by subcutaneous to 8 of randomized subjects once. | Drug: Leuplin Inj. 3.75 mg<br>* Single injection, subcutaneous injection<br>* Other names: Leuplin.Inj;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmenopausal, CKD-841, Leuplin