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Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration

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ClinicalTrials.gov Identifier: NCT01306123
Recruitment Status : Completed
First Posted : March 1, 2011
Last Update Posted : November 3, 2014
Sponsor:
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.

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
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01306123


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

Responsible Party: Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier: NCT01306123     History of Changes
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:
bioavailability
pharmacokinetics
cyanocobalamin
intranasal
intramuscular

Additional relevant MeSH terms:
Vitamins
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics