Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration

Swedish Orphan Biovitrum16 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Focus: Bioavailability

Interventions

Nascobal nasal spray (cyanocobalamin, USP)DRUG

Single intranasal administration

Vitamin B12-ratiopharm N, injection solutionDRUG

One single intramuscular administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Karolinska Trial Alliance, Karolinska University Hospital, Huddinge

Stockholm, Stockholm County, Sweden

Outcomes

Primary Outcomes

Relative bioavailability

Relative bioavailability (Frel) based on the area under the serum concentration-time curve during 72 hours (AUC0-72h) for the test and reference products.

Time frame: 0-72 hours

Secondary Outcomes

Additional PK characteristics

Maximum serum concentration (Cmax), time of Cmax (tmax) and AUC0-24h.

Time frame: 0-72h

Data from ClinicalTrials.gov

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