Status:
COMPLETED
CKD-841 Pharmacokinetic/Pharmacodynamic Study
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Collaborating Sponsors:
Severance Hospital
Conditions:
Postmenopausal Disorder
Eligibility:
FEMALE
40-65 years
Phase:
PHASE1
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 inject...
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
- 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
- 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
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03233932
Start Date
April 1 2016
End Date
July 1 2017
Last Update
July 31 2017
Active Locations (1)
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1
Severance Hospital
Seoul, Yonsei-ro, Seodaemun-gu 50-1, South Korea, 03722