A Pharmacokinetic Drug Interaction Between Fimasartan and Linagliptin in Healthy Volunteers
| Autor: | Woo Youl Kang, Young-Ran Yoon, Sook Jin Seong, Dong Heon Yang, Mi-Ri Gwon, Hae Won Lee, Wang-Seob Shim, Kyung-Tae Lee, Seung Il Cho |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Pharmacology medicine.medical_specialty business.industry Urology Cmax Pharmaceutical Science Drug interaction Linagliptin Angiotensin II 03 medical and health sciences 030104 developmental biology 0302 clinical medicine Pharmacokinetics 030220 oncology & carcinogenesis Concomitant Drug Discovery medicine Fimasartan Adverse effect business medicine.drug |
| Zdroj: | Drug Design, Development and Therapy. 14:2101-2111 |
| ISSN: | 1177-8881 |
| DOI: | 10.2147/dddt.s248205 |
| Popis: | Objective Fimasartan, an angiotensin II type 1 receptor blocker, and linagliptin, a dipeptidyl-peptidase-4 inhibitor, are frequently coadministered to treat patients with hypertension and diabetes, respectively. This study sought to evaluate the pharmacokinetic interactions between fimasartan and linagliptin after co-administration in healthy Korean subjects. Methods The overall study was divided into two separate parts, with each part designed as an open-label, multiple-dose, two-period, and single-sequence study. In Part A, to investigate the effect of linagliptin on fimasartan, 25 subjects received 120 mg fimasartan alone once daily for seven days during Period I, and 120 mg fimasartan with 20 mg linagliptin for seven days during Period II. In Part B, to examine the effect of fimasartan on linagliptin, 12 subjects received only linagliptin once daily for seven days during Period I, followed by concomitant administration of fimasartan for seven days during Period II, at the same doses used in Part A. Serial blood samples were collected at scheduled intervals for up to 24 h after the last dose to determine the steady-state pharmacokinetics of both drugs. Results Thirty-six subjects completed the study. The geometric mean ratio and 90% confidence intervals for maximum plasma concentration at steady state (Cmax,ss) and area under the concentration-time curve at steady state (AUCτ,ss) of fimasartan with or without linagliptin were 1.2633 (0.9175-1.7396) and 1.1740 (1.0499-1.3126), respectively. The corresponding values for Cmax,ss and AUCτ,ss of linagliptin with or without fimasartan were 0.9804 (0.8480-1.1336) and 0.9950 (0.9322-1.0619), respectively. A total of eight adverse events (AEs) were reported and the incidence of AEs did not increase significantly with co-administration of the drugs. Conclusion Our results suggest that there are no clinically significant pharmacokinetic interactions between fimasartan and linagliptin when co-administered. Treatments were well tolerated during the study, with no serious adverse effects. Clinical trial registry http://clinicaltrials.gov, NCT03250052. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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