MedTrace Logo

Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration

NCT01306123 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-11-03

No results posted yet for this study

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).

Conditions

  • Focus: Bioavailability

Interventions

DRUG

Nascobal nasal spray (cyanocobalamin, USP)

Single intranasal administration

DRUG

Vitamin B12-ratiopharm N, injection solution

One single intramuscular administration

Sponsors & Collaborators

  • Swedish Orphan Biovitrum

    lead INDUSTRY

Principal Investigators

  • Nabil Al-Tawil, MD, PhD · Karolinska Trial Alliance

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01306123 on ClinicalTrials.gov