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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01306123 |
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Date of registration:
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28/02/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration
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Scientific 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 |
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Date of first enrolment:
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February 2011 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01306123 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Nabil Al-Tawil, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Karolinska Trial Alliance |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Focus: Bioavailability
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Intervention(s)
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Drug: Nascobal nasal spray (cyanocobalamin, USP)
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Drug: Vitamin B12-ratiopharm N, injection solution
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Primary Outcome(s)
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Relative bioavailability
[Time Frame: 0-72 hours]
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Secondary Outcome(s)
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Additional PK characteristics
[Time Frame: 0-72h]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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