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.
Completed
- Conditions
- hereditary tyrosinemia type 110027424
- Registration Number
- NL-OMON37007
- Lead Sponsor
- Swedish Orphan International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
healthy male subjects
18-55 yrs, inclusive
BMI: 18.5-30.0 kg/m2, inclusive
smoking <<= 10 cigarettes per day
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The area under the serum concentration vs. time profile during 72 hours after<br /><br>dose (AUC72h).<br /><br>The maximum serum concentration (Cmax).</p><br>
- Secondary Outcome Measures
Name Time Method <p>AUC72h, AUC from time zero to infinity (AUC*), Cmax, time to reach Cmax (tmax),<br /><br>terminal half-life (t**z), oral clearance (CL/F), and apparent volume of<br /><br>distribution (Vz/F).<br /><br>AEs, clinical chemistry, hematology, urinalysis. </p><br>