Study to determine the potential pharmacokinetic interaction of candesartan cilexetil, atorvastatin as atorvastatin calcium trihydrate and amlodipine as amlodipine besilate at steady state after a multiple oral administration and to monitor the safety of the co-administration of these drugs. This study aims to determine if the steady state study pharmacokinetic parameters of any of the given drugs and the tolerability is altered when administered concomitantly.
This study was an open-label, comparative, multiple-dose, fixed sequence steady state trial to compare the pharmacokinetic of candesartan cilexetil, atorvastatin as atorvastatin calcium trihydrate, amlodipine as amlodipine besilate given as a multiple dose under fasting conditions in the absence and presence of each other. Bioanalysis of candesartan, atorvastatin and amlodipine is performed by LC/MS/MS method.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
compare the pharmacokinetic of candesartan cilexetil, atorvastatin as atorvastatin calcium trihydrate, amlodipine as amlodipine besilate from reference products given as a multiple dose
International Pharmaceutical Research Center
Amman, Jordan
Maximum Plasma concentration at steady state (Cmaxss)
Maximum plasma concentration, it is read directly from the raw data
Time frame: up to 24 hours post-administration at steady state
Area under the Plasma concentration curve (AUC0-t)
Area under the plasma concentration curve from time 0 to the last measured (AUC0-t)
Time frame: up to 24 hours post-administration at steady state
Safety measurement (Adverse Events)
All observed or volunteered safety events regardless of treatment group or suspected causal relationship to the investigational product(s) will be reported during study.
Time frame: complete study, Day 1 until Day 31 (Follow-up)
Time until Cmaxss is reached (tmaxss)
Time until Cmax is reached, it is read directly from the observed concentrations
Time frame: up to 24 hours post-administration at steady state
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