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Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:
NCT01306123
First received: February 28, 2011
Last updated: October 31, 2014
Last verified: October 2014
  Purpose

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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ 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.


Secondary Outcome Measures:
  • Additional PK characteristics [ Time Frame: 0-72h ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier: NCT01306123     History of Changes
Other Study ID Numbers: NSB09/17
Study First Received: February 28, 2011
Last Updated: October 31, 2014
Health Authority: Sweden: Medical Products Agency

Keywords provided by Swedish Orphan Biovitrum:
bioavailability
pharmacokinetics
cyanocobalamin
intranasal
intramuscular

Additional relevant MeSH terms:
Hydroxocobalamin
Pharmaceutical Solutions
Vitamin B 12
Vitamin B Complex
Vitamins
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014