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Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01306123
Recruitment Status : Completed
First Posted : March 1, 2011
Last Update Posted : November 3, 2014
Information provided by (Responsible Party):
Swedish Orphan Biovitrum

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).

Condition or disease Intervention/treatment Phase
Focus: Bioavailability Drug: Nascobal nasal spray (cyanocobalamin, USP) Drug: Vitamin B12-ratiopharm N, injection solution Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Nascobal nasal spray (cyanocobalamin USP)
One single administration of intranasal cyanocobalamin (initially)
Drug: Nascobal nasal spray (cyanocobalamin, USP)
Single intranasal administration

Active Comparator: Vitamin B12-ratiopharm N, injection solution
One single injection of IM cyanocobalamin (initially)
Drug: Vitamin B12-ratiopharm N, injection solution
One single intramuscular administration

Primary Outcome Measures :
  1. Relative bioavailability [ Time Frame: 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 Outcome Measures :
  1. Additional PK characteristics [ Time Frame: 0-72h ]
    Maximum serum concentration (Cmax), time of Cmax (tmax) and AUC0-24h.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01306123

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Karolinska Trial Alliance, Karolinska University Hospital, Huddinge
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Swedish Orphan Biovitrum
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Principal Investigator: Nabil Al-Tawil, MD, PhD Karolinska Trial Alliance
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Responsible Party: Swedish Orphan Biovitrum Identifier: NCT01306123    
Other Study ID Numbers: NSB09/17
First Posted: March 1, 2011    Key Record Dates
Last Update Posted: November 3, 2014
Last Verified: October 2014
Keywords provided by Swedish Orphan Biovitrum:
Additional relevant MeSH terms:
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Vitamin B 12
Growth Substances
Physiological Effects of Drugs
Vitamin B Complex