...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Drug research >Pharmacokinetic and Tolerability Comparison of Sustained and Immediate Release Oral Formulations of Nifedipine Tablet Formulations: A Single-Dose, Randomized, Open-Label, Two-Period, Two-Way Crossover Study in Healthy, Fasting Egyptian Male Volunteers
【24h】

Pharmacokinetic and Tolerability Comparison of Sustained and Immediate Release Oral Formulations of Nifedipine Tablet Formulations: A Single-Dose, Randomized, Open-Label, Two-Period, Two-Way Crossover Study in Healthy, Fasting Egyptian Male Volunteers

机译：药代动力学和可耐受性比较NifeDipine片剂配方的持续和立即释放口服配方：一种单剂量，随机，开放标签，两期，双向交叉研究健康，禁食埃及男性志愿者

获取原文
获取原文并翻译 | 示例
   

获取外文期刊封面封底 >>

       
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Nifedipine is one of calcium channel blockers that commonly used clinically to treat hypertension and angina in Egyptian patients. A sustained-release (SR) formulation of nifedipine is available in the Egyptian community and administered twice daily. This study aimed to to compare the pharmacokinetics and safety profiles of a 20 mg SR and IR (immediate release) formulation of nifedipine after single-dose administration in healthy Egyptian subjects. Randomized, crossed open-label two- way clinical trial, in 16 healthy adult volunteers, of 24.75 +/- 5.20 years, with BMI 23.26 +/- 1.756 were assessed. Blood samples were collected at predefined times for 48 h and analyzed for Nifedipine plasma concentrations using validated reversed phase liquid chromatography method with ultraviolet detection. Pharmacokinetics was determined using non- compartmental model pharmacokinetics and analyzed using one-way ANOVA (P <= 0.05). Following a single oral administration, SR formulation had a lower C (max) , compared to IR formulation (54.46 +/- 17.75 , 107.45 +/- 29.85 ng/mL, respectively), and T (max) was significantly longer (2.97 vs. 1.13 h) for the SR and IR formulation, respectively. There was no significant difference between the SR and the IR formulations for AUC (0-last) and AUC (0-infinity) (326.7 +/- 98.28 vs. 309.27 +/- 105.53 ng center dot h center dot mL (-1) and 380.9 +/- 105.24 vs. 334.36 +/- 108.1 ng center dot h center dot mL (-1) , respectively). SR formulation of nifedipine showed similar pharmacokinetics to the IR Formulation (F%=1.049), but it additionally allows a less frequent administration. Therefore, The nifedipine SR and IR formulations were well tolerated and displayed comparable safety profiles.
机译：NifeDipine是钙通道阻滞剂之一，其常用于临床上以治疗埃及患者的高血压和心绞痛。埃及社区中可获得尼弗哌单的持续释放（SR）制剂，每天两次施用。本研究旨在比较健康埃及受试者单剂量施用后硝苯地平20毫克SR和IR（即时释放）制剂的药代动力学和安全谱。随机交叉开放标签双向临床试验，16名健康成人志愿者，24.75 +/- 5.20年，评估了BMI 23.26 +/- 1.756。在预定时间内收集血液样品48小时，并使用具有紫外检测的验证的逆相液相色谱法分析硝苯地平血浆浓度。使用非室内模型药代动力学测定药代动力学，并使用单向ANOVA分析（P <= 0.05）。在单个口服给药后，与IR配方相比，SR配方具有较低的C（最大）（54.46 +/- 17.75,107.45 +/- 29.85ng / ml，分别）和T（最大值）明显更长（2.97 Vs 。1.13 H）分别为SR和IR配方。 SR与AUC（0-LAST）和AUC（0-无穷大的IR配方之间没有显着差异（326.7 +/- 98.28与309.27 +/- 105.53 Ng中心点H中心点ML（-1）和380.9 +/- 105.24与334.36 +/- 108.1 ng中心点H中心点M1（-1））。硝苯地平的SR配方显示出类似的药代动力学对IR配方（F％= 1.049），但另外允许频繁的施用较少。因此，硝化吡啶Sr和IR配方良好耐受并显示出可比的安全谱。

著录项

相似文献

  • 外文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号