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The objective of this study was to compare the pharmacokinetic (PK) profiles of HCP1401, a fixed\u2010dose combination of amlodipine 5 mg, losartan 100 mg, and chlorthalidone 25 mg, with the separate components (loose combination) of amlodipine\/losartan 5\/100 mg and chlorthalidone 25 mg. A randomized, open\u2010label, single\u2010dose, 2\u2010way crossover study was conducted. Blood samples for amlodipine and chlorthalidone were collected for up to 144 hours after dosing, whereas those for losartan were collected up to 48 hours after dosing. The PK parameters of these drugs were calculated using a noncompartmental method. Sixty subjects completed the study. The geometric mean ratios and 90% confidence intervals of maximum plasma concentration and area under the concentration\u2013time curve to the last measurable point for amlodipine, losartan, and chlorthalidone were within the conventional bioequivalence range of 0.80 to 1.25. There were no clinically significant changes in safety assessments, and the treatments were well tolerated. The PK characteristics and tolerability profiles of a single oral FDC of amlodipine, losartan, and chlorthalidone were equivalent to those of individual tablets in a loose combination.<\/jats:p>","DOI":"10.1002\/cpdd.963","type":"journal-article","created":{"date-parts":[[2021,6,23]],"date-time":"2021-06-23T03:54:20Z","timestamp":1624420460000},"page":"91-99","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Pharmacokinetics of a Fixed\u2010Dose Combination of Amlodipine\/Losartan and Chlorthalidone Compared to Concurrent Administration of the Separate Components"],"prefix":"10.1002","volume":"11","author":[{"given":"Inseung","family":"Jeon","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Seoul National University College of Medicine and Hospital  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seol 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