CKD-841 Pharmacokinetic/Pharmacodynamic Study

Chong Kun Dang

Status and phase

Completed

Phase 1

Conditions

Postmenopausal Disorder

Treatments

Drug: LeuplinⓡInj

Drug: CKD-841

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03233932

155HPS14022

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

Female

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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