Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-05-31

Brief Summary

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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).

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Detailed Description

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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

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Focus: Bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nascobal nasal spray (cyanocobalamin USP)

One single administration of intranasal cyanocobalamin (initially)

Group Type EXPERIMENTAL

Nascobal nasal spray (cyanocobalamin, USP)

Intervention Type DRUG

Single intranasal administration

Vitamin B12-ratiopharm N, injection solution

One single injection of IM cyanocobalamin (initially)

Group Type ACTIVE_COMPARATOR

Vitamin B12-ratiopharm N, injection solution

Intervention Type DRUG

One single intramuscular administration

Interventions

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Nascobal nasal spray (cyanocobalamin, USP)

Single intranasal administration

Intervention Type DRUG

Vitamin B12-ratiopharm N, injection solution

One single intramuscular administration

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes