NCT01306123

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Swedish Orphan Biovitrum · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Focus: Bioavailability

Interventions

Type	Name	Description
DRUG	Nascobal nasal spray (cyanocobalamin, USP)	Single intranasal administration
DRUG	Vitamin B12-ratiopharm N, injection solution	One single intramuscular administration

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2011-03-01
• Last updated: 2014-11-03

Locations

1 site across 1 country: Sweden