Clinical trials: sponsored by Swedish Orphan Biovitrum
Rare Diseases
A Study to Evaluate Emapalumab in Japanese Healthy Volunteers.
This is a randomized, placebo controlled and double-blinded study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and safety of a single dose (1 mg/kg) of emapalumab in adult healthy Japanese subjects.
- Trial name
- NCT04765553
- Testing
- NI-0501, Saline
- Where
- Japan
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Healthy
Bioequivalence of Orfadin 20 mg Compared to Orfadin 10 mg Capsules.
The purpose of this study is to evaluate the bioequivalence between Orfadin 20 mg and 10 mg capsules in healthy volunteers.
- Trial name
- NCT01857362
- Testing
- Nitisinone 20 mg, Nitisinone 10 mg
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Oral Mucositis
Study to Characterize the Effect of Heparin on Palifermin Activity
The purpose of this study is to evaluate the effect of a continuous intravenous infusion of unfractionated heparin on the multiple-dose pharmacodynamics of palifermin in healthy adult subjects.
- Trial name
- NCT01163097
- Testing
- Palifermin, Heparin
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Healthy Volunteers
Bioequivalence of Orfadin Suspension Compared to Orfadin Capsules, and the Effect of Food on the Bioavailability of the Suspension
The study is primarily being performed in order to demonstrate bioequivalence between the Orfadin (nitisinone) suspension and the marketed capsule formulation.
- Trial name
- NCT01682538
- Testing
- Nitisinone, capsule, Nitisinone, suspension
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum