A Comparative Pharmacokinetic and Pharmacodynamic Study of Morning Versus Evening Administration of Valsartan in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters
研究概览
简要总结
The choice of drug administration time may affect the pharmacokinetics and/or drug response, and knowledge of any such circadian rhythm-dependent effects may help to reduce side effects or to enhance efficacy. This study designed to investigate the potential influence of the time of drug administration on the pharmacokinetics and pharmacodynamics of the valsartan in healthy subjects.
详细描述
International guidelines recommend the use of long acting, once-daily medications that provide 24h efficacy; they improve adherence to therapy and minimize BP variability with smoother and more consistent BP control.
Valsartan has been approved to be used once-daily, without any specification of treatment-time in package insert. Several trials have investigated the differential effects of morning versus evening administration of valsartan in hypertensive patients, however, the results of these studies were contradicting. Furthermore, the specific administration time dependent dose response curve have not been previously investigated. So, this study designed to investigate the potential influence of the time of drug administration on the pharmacokinetics and pharmacodynamics of the valsartan in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old and not more than 45 healthy male volunteers
- •Actual weight no more than ± 30% from ideal body weight based on sex, height, and body frame
- •Who had passed all the screening parameters including physical examination, laboratory tests.
- •Who had to be able to communicate effectively with study personnel, be literate, and able to give consent.
- •diurnal active subjects with eight hour night sleep.
- •free of any drug exposure known to interfere with the pharmacokinetics/pharmacodynamics or assay of valsartan for at least 10 days prior to the study
排除标准
- •Treatment with any known enzyme-inducing/inhibiting agents within 30 days prior to the start of the study and throughout the study.
- •Susceptibility to allergic reactions to valsartan.
- •Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.
- •Gastrointestinal diseases.
- •Renal diseases.
- •Cardiovascular diseases.
- •Pancreatic disease including diabetes.
- •Hepatic diseases.
- •Hematological disease or pulmonary disease
- •Abnormal laboratory values.
- •Subjects who have donated blood or who have been involved in multiple dosing study requiring a large volume of blood (more than 500 ml) to be drawn within 6 weeks preceding the start of the study.
- •Nocturnal active subjects
研究组 & 干预措施
morning administration
administration of single oral dose valsartan (160 mg) in the morning
干预措施: Valsartan (Drug)
evening administration
administration of single oral dose valsartan (160 mg) in the evening
干预措施: Valsartan (Drug)
结局指标
主要结局
Pharmacokinetic parameters
时间窗: blood samples will be collected for 48 hour after drug administration
elimination half life (T1/2)
pharmacodynamic parameter
时间窗: Blood samples will be measured at prespecified time points for 48 hour after drug administration
Heart rate (beat/min)
次要结局
未报告次要终点
研究者
Noha Osama Mansour
Ph.D candidate Clinical pharmacy department, Faculty of pharmacy, Ain shams University
Ain Shams University