Review Article
Volume 5 Issue 8 - 2018
Pharmacokinetic Properties of a Fixed-Dose Combination of Bisoprolol and Amlodipine
Ulrike Gottwald-Hostalek and Sumedh Gaikwad*
Merck KGaA, Darmstadt, Germany
*Corresponding Author: Sumedh Gaikwad, RD-EVQ-Q Established Products Department, Merck KGaA, Darmstadt, Germany.
Received: June 14, 2018; Published: July 12, 2018
Citation: Ulrike Gottwald-Hostalek and Sumedh Gaikwad. “Pharmacokinetic Properties of a Fixed-Dose Combination of Bisoprolol and Amlodipine”. EC Cardiology 5.8 (2018): 523-532.
Abstract
For the treatment of hypertension, a fixed dose combination (FDC) tablet of bisoprolol and amlodipine in four strengths was developed for patients, whose blood pressure can be adequately controlled by simultaneously given amlodipine and bisoprolol of the same doses.
For this third-line or substitution treatment, bioequivalence between the free and the fixed-dose could be demonstrated in three bioequivalence studies, two with the highest dose of 10 mg/10 mg carried out in Canada and Brazil, and one with the lowest dose of 5 mg/5 mg done in China. A dose interaction study could clearly show that there is no relevant interaction between the two compounds, bisoprolol and amlodipine. In none of the PK studies, any severe or serious adverse event was documented, neither any clinically significant deviations in vital signs, ECG or laboratory data.
Keywords: Pharmacokinetic Properties; Bisoprolol; Amlodipine
Copyright: © 2018 Ulrike Gottwald-Hostalek and Sumedh Gaikwad. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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