Trials / Completed
CompletedNCT03364998
BAY94-9027 PK Study Comparing to Another Long Acting Product
Single Dose, Open Label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters of BAY 94 9027 and Elocta
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta after intravenous administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Damoctocog (Jivi, BAY94-9027) | 60 international units (IU)/kg, given as a 10 minute injection, 1 dose |
| DRUG | Elocta | 60 IU/kg, given as a 10 minute injection, 1 dose |
Timeline
- Start date
- 2017-11-30
- Primary completion
- 2018-01-25
- Completion
- 2018-09-28
- First posted
- 2017-12-07
- Last updated
- 2019-09-09
Locations
1 site across 1 country: Bulgaria
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03364998. Inclusion in this directory is not an endorsement.