An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Favipiravir from Flupirava 200 mg tablet (European Egyptian Pharmaceutical Industries, Egypt) versus Avigan 200 mg Tablets (Man. by Toyama Chemical Co., Ltd Japan) in Healthy Human Volunteers Under Fasting Condition.
Primary Pharmacokinetic Parameters: Cmax, 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
Purpose
OTHER
Masking
NONE
Enrollment
26
Genuine Research Center GRC
Cairo, Egypt
Cmax
Maximal measured plasma concentration
Time frame: Up to 36 hours post dose in each treatment period
Time of the maximum plasma concentration (Tmax)
The amount of time that a drug is present at the maximum concentration in serum
Time frame: Up to 36 hours post dose in each treatment period
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