The Difference in Pharmacokinetics and Pharmacodynamics between Extended-Release Fluvastatin and Immediate-Release Fluvastatin in Healthy Chinese Subjects
المؤلفون المشاركون
Xu, H. R.
Chen, W. L.
Chu, N. N.
Li, X. N.
Zhu, J. R.
المصدر
العدد
المجلد 2012، العدد 2012 (31 ديسمبر/كانون الأول 2012)، ص ص. 1-4، 4ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2012-07-01
دولة النشر
مصر
عدد الصفحات
4
التخصصات الرئيسية
الملخص EN
The aim of this study was to evaluate the difference in pharmacokinetics and pharmacodynamics between extended-release (ER) fluvastatin tablet and its immediate-release (IR) capsule in Chinese healthy subjects.
This was an open-label, single/multiple-dose, two-period, two-treatment, crossover, randomized trial with a minimum washout period of 7 days.
Twenty healthy male adult subjects were given fluvastatin ER tablet 80 mg QD by oral administration or fluvastatin IR capsule 40 mg BID for seven days.
Blood samples were collected up to 24 hours after dosing on day 1 and day 7.
Serum concentrations of fluvastatin were determined by LC-MS/MS.
For fluvastatin ER tablet 80 mg QD, Cmax was 61.0 ± 39.0 and 63.9 ± 29.7 ng/mL, and AUC0-24 h was 242 ± 156 and 253 ± 91.1 ng·h/mL on day 1 and 7, respectively.
For fluvastatin IR capsule 40 mg BID, Cmax was 283 ± 271 and 382 ± 255 ng/mL, and AUC0-24 h was 720 ± 776 and 917 ± 994 ng·h/mL on day 1 and day 7, respectively.
The relative bioavailability of fluvastatin ER tablet 80 mg QD to fluvastatin IR capsule 40 mg BID is (45.3 ± 23.9)% and (43.3 ± 24.1)% on day 1 and day 7, respectively.
Tmax for fluvastatin ER tablet was 2.50 and 2.60 h and for capsule was 0.78 and 0.88 h on day 1 and day 7, respectively.
In the first period, compared to baseline, cholesterol decreased 15.3% in fluvastatin ER tablet 80 mg QD and 16.9% in fluvastatin IR capsule 40 mg BID.
Triglyceride decreased 3.7% in fluvastatin ER tablet 80 mg QD and 19.1% in fluvastatin IR capsule 40 mg BID.
The difference has no statistical significance at P>0.05 in reduction percent of cholesterol and triglyceride between the two groups.
No adverse events were recorded.
The results indicated that Cmax of fluvastatin ER tablet is reduced and Tmax is prolonged compared with IR capsule.
There is no accumulation for ER formulation after multiple doses.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Xu, H. R.& Chen, W. L.& Chu, N. N.& Li, X. N.& Zhu, J. R.. 2012. The Difference in Pharmacokinetics and Pharmacodynamics between Extended-Release Fluvastatin and Immediate-Release Fluvastatin in Healthy Chinese Subjects. BioMed Research International،Vol. 2012, no. 2012, pp.1-4.
https://search.emarefa.net/detail/BIM-991674
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Xu, H. R.…[et al.]. The Difference in Pharmacokinetics and Pharmacodynamics between Extended-Release Fluvastatin and Immediate-Release Fluvastatin in Healthy Chinese Subjects. BioMed Research International No. 2012 (2012), pp.1-4.
https://search.emarefa.net/detail/BIM-991674
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Xu, H. R.& Chen, W. L.& Chu, N. N.& Li, X. N.& Zhu, J. R.. The Difference in Pharmacokinetics and Pharmacodynamics between Extended-Release Fluvastatin and Immediate-Release Fluvastatin in Healthy Chinese Subjects. BioMed Research International. 2012. Vol. 2012, no. 2012, pp.1-4.
https://search.emarefa.net/detail/BIM-991674
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-991674
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
تقوم هذه الخدمة بالتحقق من التشابه أو الانتحال في الأبحاث والمقالات العلمية والأطروحات الجامعية والكتب والأبحاث باللغة العربية، وتحديد درجة التشابه أو أصالة الأعمال البحثية وحماية ملكيتها الفكرية. تعرف اكثر