CKD-841 Pharmacokinetic/Pharmacodynamic Study

Phase 1

Completed

• Conditions: Postmenopausal Disorder
• Interventions: Drug: LeuplinⓡInj; Drug: CKD-841

• Registration Number: NCT03233932
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-23
• Status Verified: 2017-07
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Study First Submitted QC: 2017-07-26
• Last Update Submitted: 2017-07-26
• Study First Posted: 2017-07-31
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LeuplinⓡInj	LeuplinⓡInj	LeuplinⓡInj(=leuprorelin acetate 3.75mg)
CKD-841	CKD-841	CKD-841(=leuprorelin acetate 3.75mg)

Primary Outcome Measures

Name	Time	Method
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
Follicular Stimulating Hormone(FSH) of Leuprorelin	From before injection to up to 1008 hours post injection	Follicular Stimulating Hormone(FSH) in IU/L
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
Estradiol of Leuprorelin	From before injection to up to 1008 hours post injection	Estradiol in pg/ml

Secondary Outcome Measures

Name	Time	Method
Safety Assessment by evaluating adverse events(AEs).	From day1 to day 56	Assessment of the safety of subjects by evaluating adverse events(AEs).

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Yonsei-ro, Seodaemun-gu 50-1, Korea, Republic of