Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Amlodipine / valsartan from Amlodipine/Valsartan 10/160 film coated tablets (Pharmacare, Palestine) and Exforge 10/160 film coated tablets (Novartis Pharma, USA).
Primary Pharmacokinetic Parameters: Cmax, Area under cover (AUC0→t and AUC0→∞ ) Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%. A comprehensive final report will be issued upon the completion of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
36
1 tablet contains Amlodipine 10 mg \&valsartan 160 mg
1 tablet contains Amlodipine 10 mg \&valsartan 160 mg
Genuine Research Center GRC
Cairo, Egypt
Bioequivalence based on Cmax
Time frame: Up to 72 hours post dose in each treatment period
Bioequivalence based on AUC parameters
Time frame: Up to 72 hours post dose in each treatment period
Number of subjects with adverse events (AE)s
Safety and tolerability parameters will include recording of AEs
Time frame: Up to 72 hours post dose in each treatment period
Safety assessed by vital sign measurement
Vital sign measurement will include blood pressure, pulse rate, respiration rate and body temperature
Time frame: Up to 72 hours post dose in each treatment period
Measure of clinical laboratory test values to access safety and tolerability
Clinical laboratory tests will include hematology, clinical chemistry and urinalysis
Time frame: Up to 72 hours post dose in each treatment period
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