Bioequivalence Study of Two Nitisinone Formulations Compared to Orfadin

Inclusion Criteria: * 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: Not of childbearing potential, e.g., has been surgically sterilized, undergone a hysterectomy, amenorrhea for ≥ 12 months and considered post-menopausal, Note: In postmenopausal women, the value of the serum pregnancy test may be slightly increased. This test will be repeated to confirm the results. If there is no increase indicative of pregnancy, the female will be included in the study. OR 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 Investigational Medicinal Product (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 in…