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Am J Cardiovasc Drugs (2013) 13:17–25 DOI 10.1007/s40256-013-0006-7 OR IGINAL RESEARCH ARTIC L E Tolerability and Pharmacokinetics of Ranolazine Following Single and Multiple Sustained-release Doses in Chinese Healthy Adult Volunteers A Randomized, Open-label, Latin Square Design, Phase I Study • • • Qin-You Tan Huan-De Li Rong-Hua Zhu • • Qi-Zhi Zhang Jun Zhang Wen-Xing Peng Published online: 26 January 2013 Springer International Publishing Switzerland 2013 Abstract deviations [SDs]). Adverse events (AEs) were monitored Background and Objectives Ranolazine was approved by throughout the study via subject interview, vital signs, and the US Food and Drug Administration in January 2006 for blood sampling. the treatment of chronic angina pectoris, and is the first Results The LC-MS/MS method was developed and approved agent from a new class of anti-anginal drugs in validated. Twelve Chinese subjects (six men, six women) almost 25 years. The primary objective of this study was to were enrolled in the single-dose phase of the pharmaco- determine the concentration of ranolazine in human plasma kinetic study. The mean (SD) age of the subjects was 24.7 using the liquid chromatography/tandem mass spectrome- (1.6) years; their mean (SD) weight was 61.3 (6.4) kg, their try (LC-MS/MS) method and to compare
American Journal of Cardiovascular Drugs – Springer Journals
Published: Jan 26, 2013
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