Food-Effect on PK and PD of Single Oral Dose of CJ-12420 in Healthy Male Subjects

Phase 1 Completed 24 enrolled HK inno.N Corporation

RandomizedCrossoverOpen-labelBasic science

Summary

* Primary: To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of CJ-12420 in healthy male subjects. * Secondary * To explore food effect on the pharmacodynamics (PD) of single oral dose of CJ-12420 in healthy male subjects(PD/PK group) * To evaluate the safety of single oral dose of CJ-12420 in healthy male subjects under fed or fasting condition.

Timeline

Start: 2013-01
Primary completion: 2013-02
Completion: 2013-02

Publications

Han S, Choi HY, Kim YH, Nam JY, Kim B, Song GS, Lim HS, Bae KS. Effect of Food on the Pharmacokinetics and Pharmacodynamics of a Single Oral Dose of Tegoprazan. Clin Ther. 2021 Aug;43(8):1371-1380. doi: 10.1016/j.clinthera.2021.06.007. Epub 2021 Jul 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tegoprazan	Other / unclassified	200 mg	Oral

Indications

No indication recorded.