hereditary tyrosinemia type 1
Conditions
Interventions
All volunteers will receive, in randomized order:
- 20 mg nitisinone as 1 capsule of 20 mg
- 20 mg nitisinone as 2 capsules of 10 mg
bioequivalence
hereditary tyrosinemia type 1
Sponsors
PRA International EDS
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: healthy male and female subjects 18-55 yrs, inclusive BMI: 18.5-30.0 kg/m2, inclusive smoking
Exclusion criteria
Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor > 50 mL within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area under the serum concentration vs. time profile during 72 hours after dose (AUC72h). The maximum serum concentration (Cmax). | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC72h, AUC from time zero to infinity (AUC*), Cmax, time to reach Cmax (tmax), terminal half-life (t*z), oral clearance (CL/F), and apparent volume of distribution (Vz/F). AEs, clinical chemistry, hematology, urinalysis. | — |
Countries
Netherlands
Outcome results
None listed