Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Swedish Orphan Biovitrum
• Treatments: Hydroxocobalamin; Vitamin B 12; Vitamin B Complex; Vitamins

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