PHARMACOKINETICS OF DIFFERENT FORMULATIONS OF TELMISARTAN/AMLODIPINE FIXED-DOSE COMBINATION IN HYPERTENSIVE PATIENTS
Abstract:
Introduction: Fixed-dose combinations represent options for treating hypertension. We
investigated whether the fixed combinations of telmisartan/amlodipine followed dose-dependent kinetics.
Additional factors were considered. Material and methods: This open-label, single-center, non-randomized
clinical trial included adult hypertensive patients using fixed-dose combinations of telmisartan/amlodipine
for at least 4 weeks. Non-compartmental pharmacokinetic analysis was employed to determine the
parameters of telmisartan and amlodipine. To compare pharmacokinetics between different multiple-dosing
regimens and assessing the impact of other factors upon the pharmacokinetics, ANOVA test was used.
Results: Amlodipine displayed dose-proportional pharmacokinetics, reflected by approximately doubling
the values for Cmax and AUC in response to dosage doubling. For telmisartan, pharmacokinetics may not
necessarily follow a linear pattern. Except for BMI, there were no statistically significant differences for
amlodipine’s and telmisartan’s pharmacokinetic parameters between subgroups. Conclusions: Amlodipine
presents linear pharmacokinetics; additional studies are needed before concluding which pharmacokinetics
are attributed to telmisartan within the study dose range. BMI influences amlodipine and telmisartan
pharmacokinetic parameters.
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