Phase 1
Completed N=12
Bioequivalence of Orfadin Suspension Compared to Orfadin Capsules, and the Effect of Food on the Bioavailability of the Suspension
Healthy Volunteers
Source: ClinicalTrials.gov NCT01682538 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcomePrimary: The Area Under the Serum Concentration Curve (AUC) During 72 Hours After Dose (AUC72h) During Fasting Conditions. — 403; 346 uM*h
Summary
The study is primarily being performed in order to demonstrate bioequivalence between the Orfadin (nitisinone) suspension and the marketed capsule formulation. The study will also contain a comparison of the bioavailability of the suspension given with food and on an empty stomach.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Area Under the Serum Concentration Curve (AUC) During 72 Hours After Dose (AUC72h) During Fasting Conditions. |
403; 346 | — |
| PRIMARY The Maximum Serum Concentration (Cmax) During Fasting Conditions. |
10213; 9741 | — |
| SECONDARY The Area Under the Serum Concentration Curve (AUC) During 72 Hours After Dose (AUC72h) |
346; 350 | — |
| SECONDARY The Maximum Serum Concentration (Cmax) |
9741; 7808 | — |
| SECONDARY AUC From Time Zero to Infinity |
633; 559; 577 | — |
| SECONDARY Time to Reach C-Max (t-Max) |
3.50; 0.38; 8.00 | — |
| SECONDARY Terminal Half-life |
48.7; 53.6; 54.3 | — |
| SECONDARY Oral Clearance (CL/F) |
0.145; 0.160; 0.158 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) |
9.80; 12.2; 12.8 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male volunteers
- Age: 18-55 years, inclusive
- BMI: 18,5-30,0 kg/m2, inclusive
Exclusion Criteria
- heavy smokers
- Consumption of more than 4 cups of coffee per day.
- History of drug and/or alcohol abuse.
- Positive drug screen or alcohol breath test.
- Positive screens for hepatitis B surface antigen, hepatitis C antibodies and human immunodeficiency virus (HIV) 1-2 antibodies.
- Enrollment in another concurrent clinical study
- Intake of an investigational medicinal product within three months prior to inclusion in this study.
- Donation of more than 50 mL of blood within 60 days prior to drug administration
- Donation of more than 1, 5 liters of blood in the 10 months prior to first drug administration.
Data sourced from ClinicalTrials.gov (NCT01682538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.