Trials / Completed
CompletedNCT01653639
Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222
Single Dose, Open-label, Randomized, Crossover Study in Subjects With Severe Hemophilia A to Compare the Bioavailability of 2 Different Strengths of Kogenate FS (BAY14-2222)
- 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
This is a single dose, open-label, randomized, crossover study in subjects with severe Hemophilia A to compare the bioavailability of 2 different strengths of Kogenate FS (BAY 14-2222).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Recombinant Factor VIII (Kogenate FS, BAY14-2222) | 50 IU/kg single dose using the 3000 IU vial size (600 IU/ml) |
| BIOLOGICAL | Recombinant Factor VIII (Kogenate FS, BAY14-2222) | 50 IU/kg single dose using the 2000 IU vial size (400 IU/ml) |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
- First posted
- 2012-07-31
- Last updated
- 2014-01-10
Locations
1 site across 1 country: Bulgaria
Source: ClinicalTrials.gov record NCT01653639. Inclusion in this directory is not an endorsement.