An Open-Label, Randomized, Single Dose, Two-Way Crossover Pilot Study to Evaluate the Relative Bioavailability of One Amlodipine 5 mg Tablet and One Enalapril Maleate 20mg Tablet to a Fixed Dose Combination Tablet Formulation of Amlodipine (5 mg) and Enalapril Maleate (20 mg), in Healthy Adult Male and Female Subjects Under Fasting Conditions

The study is designed to estimate the bioavailability of amlodipine and enalapril maleate fixed dose combination (FDC) relative to co-administration of amlodipine and enalapril maleate tablets. The rational for this study is to provide a more convenient dosing regimen for patients. This is an open-label, randomized, single dose, two-way crossover study, in which 16 healthy adult male and female subjects will be enrolled and dosed under fasting conditions. Each subject will participate in two treatment periods of 7 days each. There will be at least 14 days of wash out period between the two dosing periods and a follow-up period of up to 21 days after treatment period 2. The total duration of study will be approximately 35 days from the start of the first treatment.

开始日期2013-04-03

申办/合作机构

GSK Plc

100 项与苯磺酸氨氯地平/马来酸依那普利相关的临床结果

登录后查看更多信息

100 项与苯磺酸氨氯地平/马来酸依那普利相关的转化医学

登录后查看更多信息

100 项与苯磺酸氨氯地平/马来酸依那普利相关的专利（医药）

登录后查看更多信息

项与苯磺酸氨氯地平/马来酸依那普利相关的文献（医药）

Pharmaceutics

Study of the Acidic, Basic, and Thermal Degradation Kinetics of Three Antihypertensive Drugs—Individually and in Combination

Article

作者: Škrbić, Ranko ; Gatarić, Biljana ; Mandić-Kovacević, Nebojša ; Popović Bijelić, Ana ; Kasagić-Vujanović, Irena

Background/Objectives: The importance of fixed-dose combinations (FDCs) for the treatment of hypertension is well established. However, from a stability perspective, FDCs present a challenge since the degradation of one active pharmaceutical ingredient (API) can be affected by the presence of another API. The aim of this study was to compare the degradation behaviors and evaluate the degradation kinetics of three antihypertensive drugs, perindopril tert-butylamine (PER), amlodipine besylate (AML), and indapamide (IND). Methods: The degradation processes were studied using the previously developed reverse phase high-performance liquid chromatographic (RP-HPLC) method after exposing each drug individually, as well as the combinations of two/three drugs, to different stress factors, such as light, oxidation, acidic, basic, or neutral pH values at different temperatures. Results: The results show that PER is most unstable under basic conditions and that AML displays a negative, while IND displays a positive effect, on PER stability when combined. AML is most affected by basic conditions and oxidation, and its stability is affected by both drugs positively; IND undergoes extreme photolysis, which is positively affected by AML but negatively by PER. Conclusions: Great care must be taken when formulating FDCs with these three drugs, as well as solutions or oral suspensions adjusted for geriatric or pediatric populations, since the stability of all three drugs is greatly affected by pH conditions, as well as light or oxidation factors and their interactions.

100 项与苯磺酸氨氯地平/马来酸依那普利相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
高血压	临床1期	澳大利亚	GSK Plc	-

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


[OP.LB03.07] (ESH2016)	N/A	高血压	56	Lercanidipine 10 mg/Enalapril 20 mg	獵願窪蓋顧構齋窪範網(憲壓鬱觸簾鬱淵顧糧簾) = 築蓋積蓋範構壓醖窪鑰鬱襯憲選糧願憲蓋齋艱 (餘壓鏇膚蓋艱鏇壓蓋顧, 27.1) 更多	积极	2016-09-01
				Amlodipine 5 mg/Enalapril 20 mg	獵淵網鹽網齋製鏇衊鏇(艱鏇窪遞範齋顧獵壓齋) = 糧鏇簾窪窪蓋壓膚夢餘淵願願簾蓋醖鹹襯淵蓋 (構憲艱鹽鑰蓋築繭廠鑰, 7.4)
NESTOR (ESH2016)	N/A	diabetic patients with microalbuminuria	570	Indapamide SR/amlodipine	鏇鏇襯糧蓋窪糧鑰憲鹽(糧繭選製積艱襯簾遞鏇) = 淵壓願選艱糧餘鑰製簾選窪觸憲醖壓鑰齋壓鏇 (鏇製窪窪獵鏇鏇選繭製 ) 更多	积极	2016-09-01
				Enalapril/amlodipine	鏇鏇襯糧蓋窪糧鑰憲鹽(糧繭選製積艱襯簾遞鏇) = 膚願憲鬱壓膚鹽襯繭窪選窪觸憲醖壓鑰齋壓鏇 (鏇製窪窪獵鏇鏇選繭製 ) 更多