Overview

A Study of Sofosbuvir and Ledipasvir From Magicbuvir Plus 90/400 mg Tablets (Magic Pharma, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA)

Status:
Completed

Trial end date:
2016-12-01

Target enrollment:

Participant gender:

Summary

Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir and Ledipasvir from Magicbuvir Plus 90/400 mg Tablets (Magic Pharma, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, Canada) in Healthy Human Volunteers Under Fed Condition.

Phase:

Phase 1

Details

Lead Sponsor:

Genuine Research Center, Egypt

Collaborator:

Magic Pharma, Egypt

Treatments:

Ledipasvir
Ledipasvir, sofosbuvir drug combination
Sofosbuvir