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A Bioequivalence Study of Valsartan / Amlodipine From Valsartan and Amlodipine Tablets (Hua Yuan Pharmaceutical LLC, China) and Valsartan and Amlodipine Tablets (Ⅰ) (Novartis Pharma Schweiz AG, Switzerland)

2019-09-17 02:47:44 | BioPortfolio

Summary

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).

Description

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.

Study Design

Conditions

Healthy

Intervention

Valsartan and Amlodipine Tablets

Location

The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study
Wenzhou
Zhejiang
China
325000

Status

Active, not recruiting

Source

Second Affiliated Hospital of Wenzhou Medical University

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-17T02:47:44-0400

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