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Pharmacokinetic drug interaction study using fimasartan and rosuvastatin in healthy volunteers.
Int J Clin Pharmacol Ther. 2016 Dec; 54(12):992-1003.IJ

Abstract

OBJECTIVE

This study evaluated the possible pharmacokinetic interactions between rosuvastatin and fimasartan, an angiotensin II type 1 (AT1) receptor blocker (ARB), approved in Korea for the treatment of mild to moderate hypertension.

METHODS

In this open-label, multiple-dose, two-period, single-sequence study, the enrolled subjects were randomized into two separate parts (A and B). In part A, subjects received 120 mg of fimasartan alone for 7 days during period I, and 120 mg fimasartan with 20 mg rosuvastatin for 7 days during period II. In Part B, subjects received rosuvastatin alone, followed by concomitant administration of fimasartan, with the same doses used as in Part A. There was a 7-day washout between periods I and II. Serial blood samples were collected for up to 48 hours for fimasartan and for up to 72 hours for rosuvastatin after the last dose of each period to determine the steady-state pharmacokinetics of both drugs.

RESULTS

The mean Cmax,ss and AUCτ,ss values of fimasartan were 258.03 ± 176.75 ng/mL and 746.52 ± 273.49 ng×h/mL for fimasartan alone, and 289.40 ± 231.44 ng/mL and 848.43 ± 267.45 ng×h/mL for fimasartan and rosuvastatin coadministration, respectively (p-values for Cmax,ss and AUCτ,ss, 0. 513 and 0.006, respectively). The mean Cmax,ss and AUCτ,ss values of rosuvastatin were 9.94 ± 4.48 ng/mL and 85.29 ± 36.25 ng×h/mL for rosuvastatin alone and 11.94 ± 8.47 ng/mL and 77.33 ± 38.71 ng×h/mL for fimasartan and rosuvastatin coadministration, respectively (p-values for Cmax,ss and AUCτ,ss, 0.066 and 0.009, respectively). The geometric mean ratio (GMR) and 90% confidence intervals (CI) for the Cmax,ss and AUCτ,ss of fimasartan (with/without rosuvastatin) were 1.109 (0.813 - 1.511) and 1.159 (1.061 - 1.265), respectively. The GMR and 90% CI for the Cmax,ss and AUCτ,ss of rosuvastatin (with/without fimasartan) were 1.090 (0.979 - 1.213) and 0.870 (0.804 - 0.940), respectively.

CONCLUSIONS

These results suggest that fimasartan and rosuvastatin have no relevant pharmacokinetic drug-drug interactions. All treatments were well tolerated during this study, with no serious adverse effects. .

Authors

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Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27668695

Citation

Kang, Woo Youl, et al. "Pharmacokinetic Drug Interaction Study Using Fimasartan and Rosuvastatin in Healthy Volunteers." International Journal of Clinical Pharmacology and Therapeutics, vol. 54, no. 12, 2016, pp. 992-1003.
Kang WY, Kim EH, Seong SJ, et al. Pharmacokinetic drug interaction study using fimasartan and rosuvastatin in healthy volunteers. Int J Clin Pharmacol Ther. 2016;54(12):992-1003.
Kang, W. Y., Kim, E. H., Seong, S. J., Gwon, M. R., Yang, D. H., Kim, H. J., Lim, M. S., Lee, H. W., & Yoon, Y. R. (2016). Pharmacokinetic drug interaction study using fimasartan and rosuvastatin in healthy volunteers. International Journal of Clinical Pharmacology and Therapeutics, 54(12), 992-1003.
Kang WY, et al. Pharmacokinetic Drug Interaction Study Using Fimasartan and Rosuvastatin in Healthy Volunteers. Int J Clin Pharmacol Ther. 2016;54(12):992-1003. PubMed PMID: 27668695.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pharmacokinetic drug interaction study using fimasartan and rosuvastatin in healthy volunteers. AU - Kang,Woo Youl, AU - Kim,Eun Hee, AU - Seong,Sook Jin, AU - Gwon,Mi-Ri, AU - Yang,Dong Heon, AU - Kim,Hyun-Ju, AU - Lim,Mi-Sun, AU - Lee,Hae Won, AU - Yoon,Young-Ran, PY - 2016/11/21/accepted PY - 2016/9/27/pubmed PY - 2017/11/4/medline PY - 2016/9/27/entrez SP - 992 EP - 1003 JF - International journal of clinical pharmacology and therapeutics JO - Int J Clin Pharmacol Ther VL - 54 IS - 12 N2 - OBJECTIVE: This study evaluated the possible pharmacokinetic interactions between rosuvastatin and fimasartan, an angiotensin II type 1 (AT1) receptor blocker (ARB), approved in Korea for the treatment of mild to moderate hypertension. METHODS: In this open-label, multiple-dose, two-period, single-sequence study, the enrolled subjects were randomized into two separate parts (A and B). In part A, subjects received 120 mg of fimasartan alone for 7 days during period I, and 120 mg fimasartan with 20 mg rosuvastatin for 7 days during period II. In Part B, subjects received rosuvastatin alone, followed by concomitant administration of fimasartan, with the same doses used as in Part A. There was a 7-day washout between periods I and II. Serial blood samples were collected for up to 48 hours for fimasartan and for up to 72 hours for rosuvastatin after the last dose of each period to determine the steady-state pharmacokinetics of both drugs. RESULTS: The mean Cmax,ss and AUCτ,ss values of fimasartan were 258.03 ± 176.75 ng/mL and 746.52 ± 273.49 ng×h/mL for fimasartan alone, and 289.40 ± 231.44 ng/mL and 848.43 ± 267.45 ng×h/mL for fimasartan and rosuvastatin coadministration, respectively (p-values for Cmax,ss and AUCτ,ss, 0. 513 and 0.006, respectively). The mean Cmax,ss and AUCτ,ss values of rosuvastatin were 9.94 ± 4.48 ng/mL and 85.29 ± 36.25 ng×h/mL for rosuvastatin alone and 11.94 ± 8.47 ng/mL and 77.33 ± 38.71 ng×h/mL for fimasartan and rosuvastatin coadministration, respectively (p-values for Cmax,ss and AUCτ,ss, 0.066 and 0.009, respectively). The geometric mean ratio (GMR) and 90% confidence intervals (CI) for the Cmax,ss and AUCτ,ss of fimasartan (with/without rosuvastatin) were 1.109 (0.813 - 1.511) and 1.159 (1.061 - 1.265), respectively. The GMR and 90% CI for the Cmax,ss and AUCτ,ss of rosuvastatin (with/without fimasartan) were 1.090 (0.979 - 1.213) and 0.870 (0.804 - 0.940), respectively. CONCLUSIONS: These results suggest that fimasartan and rosuvastatin have no relevant pharmacokinetic drug-drug interactions. All treatments were well tolerated during this study, with no serious adverse effects. . SN - 0946-1965 UR - https://www.unboundmedicine.com/medline/citation/27668695/Pharmacokinetic_drug_interaction_study_using_fimasartan_and_rosuvastatin_in_healthy_volunteers_ L2 - http://www.dustri.com/nc/journals-in-english?artId=14762 DB - PRIME DP - Unbound Medicine ER -