Last reviewed · How we verify
An Open, Randomized, Single-dose, Two-way Crossover Study to Characterize the Pharmacokinetic Properties of Cyanocobalamin When Administered as an Intranasal Spray and an Intramuscular Injection to Healthy Volunteers
The main purpose of this study is to assess the relative bioavailability of Nascobal Nasal Spray as compared to an IM injection of cyanocobalamin (European reference product).
Details
| Lead sponsor | Swedish Orphan Biovitrum |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 16 |
| Start date | 2011-02 |
| Completion | 2011-05 |
Conditions
- Focus: Bioavailability
Interventions
- Nascobal nasal spray (cyanocobalamin, USP)
- Vitamin B12-ratiopharm N, injection solution
Primary outcomes
- Relative bioavailability — 0-72 hours
Relative bioavailability (Frel) based on the area under the serum concentration-time curve during 72 hours (AUC0-72h) for the test and reference products.
Countries
Sweden