Focus: Bioavailability
Conditions
Keywords
bioavailability, pharmacokinetics, cyanocobalamin, intranasal, intramuscular
Brief summary
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).
Detailed description
This is an open-label, randomized, single-dose, two-way crossover study. The study consists of a screening visit, two 4-days confinement periods and a follow-up telephone call. The two confinement periods will be separated by a washout period of at least 28 days.
Interventions
DRUGNascobal nasal spray (cyanocobalamin, USP)
Single intranasal administration
DRUGVitamin B12-ratiopharm N, injection solution
One single intramuscular administration
Sponsors
Swedish Orphan Biovitrum
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy female and male voluteers * 18-40 years of age * BMI between 18.5 and 30.0 kg/m2
Exclusion criteria
* Females who are pregnant or lactating * History of clinically significant metabolic, hepatic, renal, haematological, pulmondary, cardiovascular, gastrointestinal, urological, neurological or phychiatric disorders * Serum vitamin B12 \<=250 pmol/L or MMA \>=0.40 umol/L * Evidence of significant intranasal pathology * Nasal congestion, allergic rhinitis or upper respiratory tract infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional PK characteristics | 0-72h | Maximum serum concentration (Cmax), time of Cmax (tmax) and AUC0-24h. |
Countries
Sweden
Outcome results
None listed