Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration

Phase 1

Completed

• Conditions: Focus: Bioavailability
• Interventions: Drug: Vitamin B12-ratiopharm N, injection solution; Drug: Nascobal nasal spray (cyanocobalamin, USP)

• Registration Number: NCT01306123
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-28
• Study First Submitted QC: 2011-02-28
• Study First Posted: 2011-03-01
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-31
• Last Update Posted: 2014-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vitamin B12-ratiopharm N, injection solution	Vitamin B12-ratiopharm N, injection solution	One single injection of IM cyanocobalamin (initially)
Nascobal nasal spray (cyanocobalamin USP)	Nascobal nasal spray (cyanocobalamin, USP)	One single administration of intranasal cyanocobalamin (initially)

Primary Outcome Measures

Name	Time	Method
Relative bioavailability	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

Name	Time	Method
Additional PK characteristics	0-72h	Maximum serum concentration (Cmax), time of Cmax (tmax) and AUC0-24h.

Trial Locations

Locations (1)

Karolinska Trial Alliance, Karolinska University Hospital, Huddinge; 🇸🇪 Stockholm, Sweden