Effect of multiple doses of fimasartan, an angiotensin II receptor antagonist, on the steady-state pharmacokinetics of digoxin in healthy volunteers
| Autor: | Joo Youn Cho, Jung Kwon Kim, In-Jin Jang, Choi J, Sumin Yoon, Sukyoun Shin, So Jeong Yi, Song Sh, Ji Who Kim, Jun Yk, Kyung Sang Yu, Tae Eun Kim |
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| Rok vydání: | 2011 |
| Předmět: |
Adult
Male Digoxin Cardiotonic Agents Tetrazoles Angiotensin II receptor antagonist Pharmacology Loading dose Young Adult Pharmacokinetics medicine Humans Pharmacology (medical) Fimasartan Adverse effect Morning Heart Failure Cross-Over Studies business.industry Biphenyl Compounds Arrhythmias Cardiac Crossover study Pyrimidines Area Under Curve Female business Angiotensin II Type 1 Receptor Blockers medicine.drug |
| Zdroj: | International journal of clinical pharmacology and therapeutics. 49(5) |
| ISSN: | 0946-1965 |
| Popis: | UNLABELLED Fimasartan (BR-A-657) is an angiotensin II receptor antagonist, recently approved as an antihypertensive agent. OBJECTIVE This study aimed to investigate whether administration of fimasartan has an effect on the steady-state pharmacokinetics of digoxin. METHODS An open-label, two-period, two-treatment, single-sequence, crossover study was conducted in 14 healthy male volunteers. On the first day of each 7-day treatment period, subjects received a loading dose of digoxin 0.5 mg, either alone or together with fimasartan 240 mg in the morning, followed by an additional dose of digoxin 0.25 mg after 6 h. On the subsequent 6 days, digoxin 0.25 mg, either alone or with fimasartan 240 mg was administered once daily. Serial blood samples for pharmacokinetics were collected up to 24 h after the last administration in each period. RESULTS The geometric mean ratio and 90% confidence intervals (CI) for the Cmax,ss and AUCτ,ss of digoxin (with/without fimasartan) were 1.307 (1.123 - 1.520) and 1.087 (1.015 - 1.165), respectively. Study medications were well-tolerated without serious adverse events or clinically meaningful changes. CONCLUSIONS Coadministration of fimasartan with digoxin does not result in clinically significant changes of digoxin pharmacokinetics at steady-state in healthy subjects. |
| Databáze: | OpenAIRE |
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