Pharmacokinetics Study of CJ-40001 and NESP® After Single Dose Administration in Health Male Volunteers

Phase 1 Completed 56 enrolled HK inno.N Corporation

RandomizedCrossoverSingle-blindTreatment

Summary

The purpose of this study is to compare the pharmacokinetics and safety after a single subcutaneous or intravenous administration of CJ-40001 and NESP® in healthy male volunteers.

Timeline

Start: 2014-10
Primary completion: 2014-11
Completion: 2015-12

Publications

Kim S, Hong T, Ko JW, Huh W, Kim JR. Comparison of the Pharmacokinetic-Pharmacodynamic Relationships of Two Darbepoetin Alfa Formulations in Healthy Male Volunteers. BioDrugs. 2019 Feb;33(1):101-112. doi: 10.1007/s40259-018-0323-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CJ-40001	Unknown	60 ug	Subcutaneous
Comparator	Darbepoetin alfa	Protein / enzyme biologic	60 ug	Subcutaneous

Indications

No indication recorded.