Bioequivalence Clinical Trial
Official title:
Open-Label, Randomised, Single Oral Dose, Two-Period, Cross-Over Trial To Assess The Bioequivalence Of Atafenovir 200 Mg Kapsul In Comparison With Arbidol 100 Mg Kapsul In Healthy Male Subjects Under Fasting Conditions
A single dose of Reference product containing 200 mg umifenovir hydrochloride monohydrate equivalent to 200 mg umifenovir hydrochloride and a single dose of Test product containing 200 mg umifenovir hydrochloride monohydrate equivalent to 200 mg umifenovir hydrochloride or vice versa; administered with 240 mL of water at room temperature, in each period under fasting conditions with Covid-19 Pandemic precautions.
In order to investigate the bioequivalence of all products, the 90% confidence intervals will
be calculated for the geometric mean ratios of test and reference for Cmax and AUC0-tlast of
umifenovir. These confidence intervals will then be compared with the corresponding
acceptance ranges.
In order to achieve a better approximation to a normal distribution, Cmax and AUC0-tlast data
for umifenovir will be logarithmically transformed (base e) before analysis. The sources of
variation will be treatments, periods, sequences and subjects within the sequence. Evaluation
of treatment, period, sequence and subject (nested within sequence) effects at 5% level of
significance will be performed. From the result, the two one-sided hypothesis at the 5% level
of significance will be tested by constructing the 90% confidence interval for the geometric
mean ratios of test/reference products. The confidence interval is calculated by
retransformation of the shortest confidence interval for the difference of the ln-transformed
mean values. Differences in tmax will be evaluated non-parametrically.
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