The Safety and Pharmacokinetic/Pharmacodynamic Study of CKD-841 in Postmenopausal Female, Phase 1

• Status: Not yet recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

A randomized, single-blinded, parallel design phase I clinical trial to investigate the safety and pharmacokinetics/pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. after subcutaneous injection in postmenopausal female

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Collaborator: Severance Hospital
• Treatments: Leuprolide

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 < 28.0

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 in the last three months

• 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