NCT04476719

The Bioequivalence Study of Umifenovir 200 mg Capsul (ATABAY, Turkey) Under Fasting Conditions

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Atabay Kimya Sanayi Ticaret A.S. · Industry
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	ATAFENOVIR 200 MG KAPSUL	A 200 mg capsule 0ral administration with 240 ml water
DRUG	ARBIDOL 100 MG KAPSUL	Two 100 mg capsules will be administrated with 240 ml water orally.

Timeline

• Start date: 2020-07-09
• Primary completion: 2020-07-22
• Completion: 2020-08-20
• First posted: 2020-07-20
• Last updated: 2020-07-20

Locations

2 sites across 1 country: Turkey (Türkiye)