This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration

This study has been completed.
Information provided by (Responsible Party):
Swedish Orphan Biovitrum Identifier:
First received: February 28, 2011
Last updated: October 31, 2014
Last verified: October 2014
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 Intervention Phase
Focus: Bioavailability Drug: Nascobal nasal spray (cyanocobalamin, USP) Drug: Vitamin B12-ratiopharm N, injection solution Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Swedish Orphan Biovitrum:

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

Enrollment: 16
Study Start Date: February 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01306123

Karolinska Trial Alliance, Karolinska University Hospital, Huddinge
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Swedish Orphan Biovitrum
Principal Investigator: Nabil Al-Tawil, MD, PhD Karolinska Trial Alliance
  More Information

Responsible Party: Swedish Orphan Biovitrum Identifier: NCT01306123     History of Changes
Other Study ID Numbers: NSB09/17
Study First Received: February 28, 2011
Last Updated: October 31, 2014

Keywords provided by Swedish Orphan Biovitrum:

Additional relevant MeSH terms:
Vitamin B 12
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Hematinics processed this record on August 23, 2017