CKD-841 Pharmacokinetic/Pharmacodynamic Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Trial to Investigate the Safety and Pharmacokinetics/Pharmacodynamics of CKD-841 After Subcutaneous Injection in Postmenopausal Female

Conditions
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Postmenopausal Disorder

Intervention / Treatment
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* Drug: LeuplinⓡInj
* Drug: CKD-841


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 < 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LeuplinⓡInj<br>LeuplinⓡInj(=leuprorelin acetate 3.75mg) | Drug: LeuplinⓡInj<br>* Investigational drug(=LeuplinⓡInj)is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.<br>|
| Experimental: CKD-841<br>CKD-841(=leuprorelin acetate 3.75mg) | Drug: CKD-841<br>* Investigational drug(=CDK-841) is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

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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CKD-841, Leuplin, Postmenopausal