NCT04478448

Bioequivalence Study of Favipiravir From Flupirava 200 mg Tablet (European Egyptian Pharmaceutical Industries , Egypt) Versus Avigan 200 mg Tablets (Man. by Toyama Chemical Co., Ltd Japan)

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Genuine Research Center, Egypt · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Flupirava	1 tablet contains 200 mg Favipiravir
DRUG	Avigan	1 tablet contains 200 mg Favipiravir

Timeline

• Start date: 2020-08-13
• Primary completion: 2020-08-20
• Completion: 2020-08-26
• First posted: 2020-07-20
• Last updated: 2020-09-02

Locations

1 site across 1 country: Egypt