Assessment of the drug-drug interactions between fimasartan and hydrochlorothiazide in healthy volunteers

Hyewon Jeon, Kyoung Soo Lim, Kwang Hee Shin, Jaewoo Kim, Seo Hyun Yoon, Joo Youn Cho, Sang Goo Shin, In Jin Jang, Kyung Sang Yu

Research output: Contribution to journalArticlepeer-review

20 Scopus citations

Abstract

AIM: Fimasartan is a selective angiotensin II receptor blocker. Hydrochlorothiazide (HCTZ), which is used to treat hypertension and edematous conditions, is coadministered with many antihypertensive agents. METHODS: An open-label, randomized, multiple-dosing, 2-arm, 1-sequence, 2-period study was conducted to assess the effects of fimasartan (240 mg) on HCTZ (25 mg) or vice versa in 18 and 14 healthy male volunteers, respectively. During each drug administration period, drugs were given once daily for 7 days, with a 7-day washout period between the 2 administration periods. RESULTS: The respective geometric mean ratios of fimasartan for AUC τ,ss and C max,ss with HCTZ were 1.30 [90% confidence interval (CI), 0.84-2.01] and 1.17 (90% CI, 0.93-1.47) compared with fimasartan alone. The respective geometric mean ratios of HCTZ for AUC τ,ss and C max,ss with fimasartan were 0.94 (90% CI, 0.84-1.04) and 0.88 (90% CI, 0.80-0.97) compared with HCTZ alone. Plasma renin activity indicated no significant differences between fimasartan monotherapy and coadministered treatment. CONCLUSIONS: Fimasartan administered alone or in combination with HCTZ was well tolerated at the described dosages. Coadministration of fimasartan increased the urinary excretion of HCTZ and urine volume, but these observations are unlikely to have any clinical relevance.

Original languageEnglish
Pages (from-to)84-91
Number of pages8
JournalJournal of Cardiovascular Pharmacology
Volume59
Issue number1
DOIs
StatePublished - Jan 2012

Keywords

  • drug-drug interaction
  • fimasartan
  • hydrochlorothiazide
  • pharmacokinetics

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