Healthy Volunteers Clinical Trial
Official title:
Open Label, Comparative, Multiple-dose, Fixed-sequence Steady State Trial in Healthy Volunteers to Assess the Pharmacokinetic Interaction of Candesartan, Atorvastatin and Amlodipine After a Multiple Oral Dose Administration
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.
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