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Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration

This study has been completed.
Sponsor:
Information provided by:
Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:
NCT01306123
First received: February 28, 2011
Last updated: June 8, 2011
Last verified: June 2011
History of Changes

February 28, 2011
June 8, 2011
February 2011
May 2011   (final data collection date for primary outcome measure)
Relative bioavailability [ Time Frame: 0-72 hours ] [ Designated as safety issue: No ]
Relative bioavailability (Frel) based on the area under the serum concentration-time curve during 72 hours (AUC0-72h) for the test and reference products.
Same as current
Complete list of historical versions of study NCT01306123 on ClinicalTrials.gov Archive Site
Additional PK characteristics [ Time Frame: 0-72h ] [ Designated as safety issue: No ]
Maximum serum concentration (Cmax), time of Cmax (tmax) and AUC0-24h.
Same as current
Not Provided
Not Provided
 
Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration
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

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).

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Focus: Bioavailability
  • Drug: Nascobal nasal spray (cyanocobalamin, USP)
    Single intranasal administration
  • Drug: Vitamin B12-ratiopharm N, injection solution
    One single intramuscular administration
  • Experimental: Test product
    One single administration of intranasal cyanocobalamin (initially)
    Intervention: Drug: Nascobal nasal spray (cyanocobalamin, USP)
  • Active Comparator: Reference product
    One single injection of IM cyanocobalamin (initially)
    Intervention: Drug: Vitamin B12-ratiopharm N, injection solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01306123
NSB09/17
No
Sari von Reedtz, Clinical Program Leader, Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
Swedish Orphan Biovitrum
Not Provided
Principal Investigator: Nabil Al-Tawil, MD, PhD Karolinska Trial Alliance
Swedish Orphan Biovitrum
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP