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Comparative randomized, single dose, three periods, three-way crossover open-label study to determine the bioequivalence of Valsartan and Amlodipine Tablets (Hua yuan Pharmaceutical LLC, China) and Valsartan and Amlodipine Tablets (Ⅰ) (Novartis Pharma Schweiz AG, Switzerland).
Primary Pharmacokinetic Parameters: Cmax, Area under cover (AUC0→t and AUC0→∞ ) .Secondary Pharmacokinetic Parameters: tmax and t1/2. The method of judging bioequivalence of three-cross-section repeating experiment design: first of all, the calculation of the SWR of the AUC and Cmax, if SWR≥0.294, the use of RSABE analysis; if Swr<0.294, the average Bioequivalence analysis method with Non-scale (bioequivalence limit is 80%~125 %）.
A comprehensive final report will be issued upon the completion of the study.
Valsartan and Amlodipine Tablets
Active, not recruiting
Second Affiliated Hospital of Wenzhou Medical University
Published on BioPortfolio: 2019-09-17T02:47:44-0400
The purpose of the present study is to assess the non-inferiority of the efficacy and safety of fixed dose combination of 5 mg amlodipine and 80 mg valsartan compared to 160 mg valsartan i...
This trial will compare valsartan and amlodipine combination therapies to valsartan and amlodipine monotherapy,and placebo for treating patients with hypertension
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A pharmaceutical preparation of amlodipine and valsartan that is used for the treatment of HYPERTENSION.
Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
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