Overview

A Study of Sofosbuvir and Ledipasvir From Soviredia 90/400 mg Tablets (Minapharm, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA)

Status:
Completed

Trial end date:
2017-05-28

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 Soviredia 90/400 mg Tablets (Minapharm, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA) in Healthy Human Volunteers Under Fasting Condition.

Phase:

Phase 1

Details

Lead Sponsor:

Genuine Research Center, Egypt

Collaborator:

MinaPharm Pharmaceuticals

Treatments:

Ledipasvir
Ledipasvir, sofosbuvir drug combination
Sofosbuvir