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

Inclusion Criteria: * Healthy male and female subjects, 18 to 55 years (both inclusive) at signing of informed consent. * Body Mass Index (BMI) between 18.5 and 30 kg/m2 (inclusive). * Body mass not less than 50 kg. * Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the investigator considers the deviation to be irrelevant for the purpose of the study. * Non-smokers. * Females, if: Of childbearing potential, the following conditions are to be met: * Negative pregnancy test If this test is positive, the subject will be excluded from the study. In the rare circumstance that a pregnancy is discovered after the subject received IMP, every attempt must be made to follow her to term. * Not lactating * Abstaining from sexual activity (if this is the usual lifestyle of the subject) or must agree to use an accepted method of contraception, and agree to continue with the same method throughout the study Examples of reliable methods of contraception include non-hormonal intrauterine device, and barrier methods combined with an additional contraceptive method. In this study the concomitant use of hormonal contraceptives is NOT allowed. Other methods, if considered by the investigator as reliable, will be accepted. * Written consent given for participation in the study. Exclusion Criteria: * Evidence of…