Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration

What Was Tested

This registered phase 1 trial tested Cyanocobalamin (Vitamin B12).

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).

It had two arms (groups): Nascobal nasal spray (cyanocobalamin USP) (experimental) and Vitamin B12-ratiopharm N, injection solution (active comparator).

One single administration of intranasal cyanocobalamin (initially).

One single injection of IM cyanocobalamin (initially).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 16 actual participants took part.

It was open to people of any sex aged from 18 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy female and male voluteers. 18-40 years of age. BMI between 18.5 and 30.0 kg/m2.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: females who are pregnant or lactating; nasal congestion, allergic rhinitis or upper respiratory tract infection.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Cyanocobalamin (Vitamin B12) and the comparison in turn, acting as their own control.

Everyone knew when Cyanocobalamin (Vitamin B12) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2011-02 with completion listed for 2011-05.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Relative bioavailability (time frame: 0-72 hours).

It also tracked 1 secondary outcome, for example Additional PK characteristics.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cyanocobalamin (Vitamin B12) in 16 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.