Clinical trial NCT03233932: CKD-841 Pharmacokinetic/Pharmacodynamic Study
Official title: Clinical Trial to Investigate the Safety and Pharmacokinetics/Pharmacodynamics of CKD-841 After Subcutaneous Injection in Postmenopausal Female
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postmenopausal Disorder
Keywords: CKD-841
Leuplin
Postmenopausal
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Severance Hospital
First posted: 2017-07-31
Enrollment: 13
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak Plasma Concentration (Cmax) of Leuprorelin
timeFrame: From before injection to up to 1008 hours post injection
measure: Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) of Leuprorelin
timeFrame: From before injection to up to 1008 hours post injection
measure: Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) of Leuprorelin
timeFrame: From before injection to up to 1008 hours post injection
measure: Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) of Leuprorelin
timeFrame: From before injection to up to 1008 hours post injection
measure: The time -to-maximal serum or plasma concentrations (Tmax) of Leuprorelin
timeFrame: From before injection to up to 1008 hours post injection
measure: Terminal half-life (t1/2) Luteinizing Hormone(LH) of Leuprorelin
timeFrame: From before injection to up to 1008 hours post injection
measure: Follicular Stimulating Hormone(FSH) of Leuprorelin
timeFrame: From before injection to up to 1008 hours post injection
measure: Estradiol of Leuprorelin
timeFrame: From before injection to up to 1008 hours post injection
Secondary outcomes:
measure: Safety Assessment by evaluating adverse events(AEs).
timeFrame: From day1 to day 56
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Yonsei-ro, Seodaemun-gu 50-1
Study officials:
affiliation: Severance Hospital
name: Min Soo Park, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: