Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration

Focus: Bioavailability Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306123
• Other study ID #: NSB09/17
• Status: Completed
• Phase: Phase 1
• First received: February 28, 2011
• Last updated: October 31, 2014
• Start date: February 2011
• Est. completion date: May 2011

Study information

• Verified date: October 2014
• Source: Swedish Orphan Biovitrum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Focus: Bioavailability

Intervention

Drug:
• Nascobal nasal spray (cyanocobalamin, USP)
Single intranasal administration
• Vitamin B12-ratiopharm N, injection solution
One single intramuscular administration

Locations

Country	Name	City	State
Sweden	Karolinska Trial Alliance, Karolinska University Hospital, Huddinge	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Orphan Biovitrum

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative bioavailability	Relative bioavailability (Frel) based on the area under the serum concentration-time curve during 72 hours (AUC0-72h) for the test and reference products.	0-72 hours	No
Secondary	Additional PK characteristics	Maximum serum concentration (Cmax), time of Cmax (tmax) and AUC0-24h.	0-72h	No