Randomized, open-label, two-period crossover comparison of the pharmacokinetic and pharmacodynamic properties of two amlodipine formulations in healthy adult male Korean subjects

Clinical Therapeutics
Ji-Young ParkEak-Kyun Shin

Abstract

Amlodipine, a third-generation dihydropyridine calcium antagonist, is prescribed in the management of angina and hypertension. A newly developed amlodipine formulation (amlodipine camsylate) is associated with similar physical properties, melting point, and solubility-and improved stability against long-term stability test and accelerated temperature test-compared with the conventional formulation (amlodipine besylate). This study was performed to compare the pharmacokinetic (PK) and pharmacodynamic (PD) properties and safety profiles of a newly developed amlodipine formulation with a conventional formulation in healthy male subjects. This randomized, open-label, 2-period crossover comparative study was conducted at the Clinical Trial Center, Gil Medical Center, Gachon Medical School (Incheon, Korea). Eighteen healthy male Korean subjects aged 20 to 40 years were enrolled. All subjects received a single oral dose (5-mg tablet) of a conventional (reference) or newly developed (test) amlodipine formulation. Blood samples for PK analysis of amlodipine were obtained during the 144-hour period after dosing. Systolic and diastolic blood pressure (BP) (SBP and DBP, respectively) and pulse rate (PR) were measured just before each blood...Continue Reading

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Citations

Dec 4, 2008·JAMA : the Journal of the American Medical Association·Aaron S KesselheimWilliam H Shrank
Dec 7, 2007·Clinical and Experimental Hypertension : CHE·Fiorenzo MigniniFrancesco Amenta
Jul 28, 2006·British Journal of Clinical Pharmacology·Kyoung-Ah KimJi-Young Park
Aug 10, 2016·British Journal of Clinical Pharmacology·Young-A HeoKyungsoo Park
Nov 9, 2016·Journal of Pharmaceutics·Muhammad Ali SherazIqbal Ahmad
May 7, 2019·Basic & Clinical Pharmacology & Toxicology·Jin-Woo ParkJi-Young Park
Dec 2, 2015·European Journal of Epidemiology·Lamberto ManzoliJohn P A Ioannidis

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