Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration

Sobi

Status and phase

Completed

Phase 1

Conditions

Focus: Bioavailability

Treatments

Drug: Nascobal nasal spray (cyanocobalamin, USP)

Drug: Vitamin B12-ratiopharm N, injection solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT01306123

NSB09/17

Details and patient eligibility

About

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).

Full 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.

Enrollment

16 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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