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

NCT04840745 Phase 1 UNKNOWN

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

Details

Lead sponsor	Chong Kun Dang Pharmaceutical
Phase	Phase 1
Status	UNKNOWN
Enrolment	32
Start date	2021-04
Completion	2021-11

Conditions

• Early Puberty

Interventions

• CKD-841 A-1 3.75mg
• CKD-841 A-1 1.88mg
• CKD-841 D 2.92mg
• Leuplin Inj. 3.75 mg

Primary outcomes

• PK(Cmax) — From before injection to up to 1008 hours post injection
  Cmax(Maximum concentration of drug in plasma) of Leuprorelin
• PK(AUClast) — From before injection to up to 1008 hours post injection
  AUClast(Area under the plasma drug concentration-time curve to last measurement) of Leuprorelin
• PK(AUCinf) — From before injection to up to 1008 hours post injection
  AUCinf(Area under the plasma drug concentration-time curve extrapolated to infinity) of Leuprorelin
• PK(AUC7-t) — From before injection to up to 1008 hours post injection
  AUC7-t(Area under the plasma drug concentration-time curve from 7 days to last measurement) of Leuprorelin
• PK(CL/F) — From before injection to up to 1008 hours post injection
  CL/F(Apparent Clearance) of Leuprorelin
• PK(Vd/F) — From before injection to up to 1008 hours post injection
  Vd/F(Apparent Volume of Distribution) of Leuprorelin

Countries

South Korea