Phase 1
Completed N=12
Bioequivalence of Orfadin 20 mg Compared to Orfadin 10 mg Capsules.
Healthy
Source: ClinicalTrials.gov NCT01857362 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: The Area Under the Serum Concentration vs. Time Profile During 72 Hours After Dose (AUC72h). — 262; 267 uM*h
Summary
The purpose of this study is to evaluate the bioequivalence between Orfadin 20 mg and 10 mg capsules in healthy volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Area Under the Serum Concentration vs. Time Profile During 72 Hours After Dose (AUC72h). |
262; 267 | — |
| PRIMARY The Maximum Serum Concentration (Cmax). |
6438; 6366 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male and female volunteers between 18-55 years of age, inclusive.
- BMI between 18,5-30,0 kg/m2, inclusive.
Exclusion Criteria
- Subjects with current keratopathy, or other abnormalities found by slit-lamp examination.
- Subjects who are heavy smokers or consume more than 5 cups of coffee per day.
- Subjects with history of drug and/or alcohol abuse or a positive drug screen or alcohol breath test.
- Subjects with positive screens for hepatitis B surface antigen, hepatitis C antibodies and human immunodeficiency virus (HIV) 1-2 antibodies.
- Subjects who were enrolled in another concurrent clinical study or intake of an investigational medicinal product within three months prior to inclusion in this study.
- Subjects who donate more than 50 mL of blood within 60 days prior to drug administration or donate more than 1,5 liters of blood in the 10 months prior to first drug administration.
- Female subjects that are pregnant or breastfeeding.
- Female subjects of childbearing potential and all male subjects must be willing to use effective forms of contraception.
Data sourced from ClinicalTrials.gov (NCT01857362). 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.