A Study of Pharmacokinetics and Safety of Ranolazine PR in Healthy Korean and Caucasian Male Subjects

Phase 1 Unknown 120 enrolled A.Menarini Asia-Pacific Holdings Pte Ltd

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is: To assess the pharmacokinetic profile and safety of ranolazine PR in healthy Korean and Caucasian volunteers after oral administration of Ranolazine at the doses of 375, 500, 750mg after single and repeated oral administrations.

Timeline

Start: 2016-03
Primary completion: 2016-07
Completion: 2016-10

Publications

Yoo H, Lee SW, Yoon DY, Yoon SH, Cho JY, Yu KS, Jang IJ, Lee S. Pharmacokinetics and Safety of Extended-release Ranolazine in Korean and White Healthy Subjects. Clin Ther. 2021 Mar;43(3):526-534.e4. doi: 10.1016/j.clinthera.2021.01.005. Epub 2021 Jan 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ranolazine	Small molecule	375 mg	Oral
Subject	Ranolazine	Small molecule	500 mg	Oral
Subject	Ranolazine	Small molecule	750 mg	Oral

Indications

No indication recorded.