Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Focus: Bioavailability

Intervention / Treatment
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* Drug: Nascobal nasal spray (cyanocobalamin, USP)
* Drug: Vitamin B12-ratiopharm N, injection solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nascobal nasal spray (cyanocobalamin USP)<br>One single administration of intranasal cyanocobalamin (initially) | Drug: Nascobal nasal spray (cyanocobalamin, USP)<br>* Single intranasal administration<br>|
| Active Comparator: Vitamin B12-ratiopharm N, injection solution<br>One single injection of IM cyanocobalamin (initially) | Drug: Vitamin B12-ratiopharm N, injection solution<br>* One single intramuscular administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional PK characteristics | Maximum serum concentration (Cmax), time of Cmax (tmax) and AUC0-24h. | 0-72h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioavailability, pharmacokinetics, cyanocobalamin, intranasal, intramuscular