NCT02953535

A Bio-equivalence Study of Sofosbuvir From Magicbuvir 400 mg Film Coated Tablets ( Magic Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)

Comparative Open-label,Randomized, Fasting, Three Way Three Sequence Two Treatment Partial Replicate Crossover Bioequivalence Study of Sofosbuvir From Magicbuvir 400 mg Film Coated Tablets ( Magic Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Genuine Research Center, Egypt · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir from Magicbuvir 400 mg Film Coated Tablets ( Magic Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Magicbuvir	1 tablet contains 400 mg sofosbuvir
DRUG	Sovaldi (fist dose)	1 tablet contains 400 mg sofosbuvir
DRUG	Sovaldi (second dose)	1 tablet contains 400 mg sofosbuvir

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-11-02
• Last updated: 2016-11-02

Locations

1 site across 1 country: Egypt