NCT02750345 - Bioequivalence Study of Two Oral Nitisinone Formulations to Treat Hereditary Tyrosinemia (HT-1) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

May 31, 2016

Study Completion Date

May 31, 2016

Conditions

Hereditary Tyrosinemia, Type I

Interventions

DRUG

Nitisinone

A single oral dose of Nitisinone 10 mg Tablet will be administered.

DRUG

Nitisinone Baked Tablet

A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.

DRUG

Orfadin

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

Trial Locations (1)

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