ArticleTranslational and clinical pharmacology2025
Comparison of pharmacokinetics of a fixed-dose combination of atorvastatin/ezetimibe 5 mg/10 mg versus separate tablets in healthy subjects.
Article in Translational and clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05202405 (An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B in Healty Adult Volunteers), which is not on this map. Not yet cited in PubMed.
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An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B in Healty Adult Volunteers
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Abstract
The 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors are well-established treatment options for dyslipidemia. For patients not meeting low-density lipoprotein cholesterol targets with monotherapy, combination therapy with another lipid-lowering agent including ezetimibe, is recommended. This study compared the pharmacokinetics (PKs) and safety of a fixed-dose combination (FDC) of atorvastatin/ezetimibe 5 mg/10 mg with the individual components in healthy Korean subjects. A randomized, open-label, single-dose, 2-treatment, 2-sequence, crossover study was conducted in 60 healthy subjects. An FDC of atorvastatin/ezetimibe 5 mg/10 mg or the corresponding individual components was administered in the first period, and the alternative in the second period after a 14-day washout. Serial blood samples were collected up to 72 hours post-dose to calculate PK parameters such as maximum plasma concentration (C Trial Registration: ClinicalTrials.gov Identifier: NCT05202405.
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