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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
84
1 tablet contains Valsartan 80mg\& Amlodipine 5mg
The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study
Wenzhou, Zhejiang, China
Bioequivalence based on Cmax
Time frame: Up to 96 hours post dose in each treatment period
Bioequivalence based on AUC parameters
Time frame: Up to 96 hours post dose in each treatment period
Number of subjects with adverse events (AE)s
Safety and tolerability parameters will include recording of AEs(blood biochemistry, urine routine examination, electrocardiograph, etc.)
Time frame: Up to 96 hours post dose in each treatment period
blood pressure
Vital sign measurement will include blood pressure
Time frame: Up to 96 hours post dose in each treatment period
pulse rate
Vital sign measurement will include pulse rate
Time frame: Up to 96 hours post dose in each treatment period
respiration rate
Vital sign measurement will include respiration rate
Time frame: Up to 96 hours post dose in each treatment period
ear temperature
Vital sign measurement will include ear temperature
Time frame: Up to 96 hours post dose in each treatment period
complete blood count
Clinical laboratory tests will include CBC
Time frame: Up to 96 hours post dose in each treatment period
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