Bioequivalence Study of a Test Capsule Formulation of Fingolimod With the Reference Capsule Formulation of Fingolimod

PHASE1CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

October 23, 2015

Primary Completion Date

January 26, 2016

Study Completion Date

January 26, 2016

Conditions
Healthy Volunteers
Interventions
DRUG

Fingolimod Reference Formulation

To compare the rate and extent of absorption for Fingolimod when administered as a single oral dose of 3 x 0.5 mg capsules of the reference product produced by Novartis Pharmaceutical with the proposed test product manufactured by Asofarma S.A.I. y C. in healthy volunteers, under fasted conditions.

DRUG

Fingolimod Test Formulation

To compare the rate and extent of absorption for Fingolimod when administered as a single oral dose of 3 x 0.5 mg capsules of the proposed test product manufactured by Asofarma S.A.I. y C. with the reference product produced by Novartis Pharmaceutical in healthy volunteers, under fasted conditions.

Trial Locations (1)

9010

Zenith Clinical Site, Dunedin

All Listed Sponsors
collaborator

Zenith Technology Corporation Limited

INDUSTRY

lead

Asofarma S.A.I. y C.

INDUSTRY

NCT03757338 - Bioequivalence Study of a Test Capsule Formulation of Fingolimod With the Reference Capsule Formulation of Fingolimod | Biotech Hunter | Biotech Hunter