NCT02750709 - Bioequivalence Study of Two Nitisinone Formulations Compared to Orfadin | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

December 31, 2015

Study Completion Date

January 31, 2016

Conditions

Hereditary Tyrosinemia, Type I

Interventions

DRUG

Nitisinone

A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.

DRUG

Nitisinone 10 mg Tablet High Compritol

A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.

DRUG

Orfadin

A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state.

Trial Locations (1)

Bloemfontein Early Phase Clinical Unit, PAREXEL International (South Africa), Bloemfontein