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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nascobal nasal spray (cyanocobalamin USP) | Experimental | One single administration of intranasal cyanocobalamin (initially) |
|
| Vitamin B12-ratiopharm N, injection solution | Active Comparator | One single injection of IM cyanocobalamin (initially) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nascobal nasal spray (cyanocobalamin, USP) | Drug | Single intranasal administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative bioavailability | Relative bioavailability (Frel) based on the area under the serum concentration-time curve during 72 hours (AUC0-72h) for the test and reference products. | 0-72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Additional PK characteristics | Maximum serum concentration (Cmax), time of Cmax (tmax) and AUC0-24h. | 0-72h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nabil Al-Tawil, MD, PhD | Karolinska Trial Alliance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Trial Alliance, Karolinska University Hospital, Huddinge | Stockholm | Stockholm County | 141 86 | Sweden |
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| ID | Term |
|---|---|
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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| Vitamin B12-ratiopharm N, injection solution | Drug | One single intramuscular administration |
|
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |