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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
single oral dose of 160 mg valsartan under fasting conditions
Ain Shams university
Cairo, Egypt
Pharmacokinetic parameters
Maximum plasma concentration (Cmax),
Time frame: blood samples will be collected for 48 hour after drug administration
Pharmacokinetic parameters
Area under the curve (AUC).
Time frame: blood samples will be collected for 48 hour after drug administration
Pharmacokinetic parameters
elimination half life (T1/2)
Time frame: blood samples will be collected for 48 hour after drug administration
pharmacodynamic parameter
systolic blood pressure (mm Hg) ,diastolic blood pressure (mm Hg)
Time frame: Blood samples will be measured at prespecified time points for 48 hour after drug administration
pharmacodynamic parameter
Heart rate (beat/min)
Time frame: Blood samples will be measured at prespecified time points for 48 hour after drug administration
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