Bioequivalence of Orfadin suspension 4 mg/mL compared to Orfadin capsules 10 mg, and the effect of food on the bioavailability of the suspension. An open-label, randomized, cross-over, single-dose study in healthy volunteers.

Bioequivalence of Orfadin suspension 4 mg/mL compared to Orfadin capsules 10 mg, and the effect of food on the bioavailability of the suspension. An open-label, randomized, cross-over, single-dose study in healthy volunteers. - Bioequivalence of nitisinone oral capsule formulation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37007

Enrollment

Registered

2012-08-15

Start date

2012-08-29

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hereditary tyrosinemia type 1

Interventions

All volunteers will receive, in randomized order: - 30 mg nitisinone as 3 capsules, fasted - 30 mg nitisinone as 7,5 ml suspension for oral administration, fasted - 30 mg nitisinone as 7,5 ml suspensi

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male 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

Source: NL-OMON (via WHO ICTRP)