Overview

Bioequivalence Study of Fingolimod From Sphingomod 0.5 mg Hard Gelatin Capsules (Hikma Pharma, Egypt) Versus Gilenya 0.5 mg Hard Capsules (Novartis Pharma AG, Basle, Switzerland).

Status:
Completed

Trial end date:
2020-10-20

Target enrollment:

Participant gender:

Summary

An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Fingolimod From Sphingomod 0.5 mg Hard Gelatin Capsules (Hikma Pharma, Egypt) Versus Gilenya 0.5 mg Hard Capsules (Novartis Pharma AG, Basle, Switzerland) in Healthy Human Volunteers Under Fasting Condition.

Phase:

Phase 1

Details

Lead Sponsor:

Genuine Research Center, Egypt

Collaborator:

Hikma Pharmaceuticals LLC

Treatments:

Fingolimod Hydrochloride