Pharmacokinetics and Safety Between "DWJ1421" and "DWC201903" in Healthy Male Volunteers

Phase 1 Completed 40 enrolled Daewoong Pharmaceutical Co. LTD.

RandomizedCrossoverOpen-labelBasic science

Summary

This is a randomized, open label, single dose, crossover study to compare the pharmacokinetics and safety between "DWJ1421" and "DWC201903" in healthy male volunteers.

Timeline

Start: 2019-07-02
Primary completion: 2019-08-10
Completion: 2020-02-19

Publications

Shin W, Yang AY, Yun H, Cho DY, Park KH, Shin H, Kim A. Bioequivalence of the pharmacokinetics between tofacitinib aspartate and tofacitinib citrate in healthy subjects. Transl Clin Pharmacol. 2020 Sep;28(3):160-167. doi: 10.12793/tcp.2020.28.e13. Epub 2020 Sep 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tofacitinib	Small molecule	5 mg	Oral

Indications

No indication recorded.