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OpenTrials
Completed

NCT Number: NCT01306123

Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration

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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Key information

Conditions

Focus: Bioavailability

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Karolinska Trial Alliance, Karolinska University Hospital, Huddinge

Stockholm, Stockholm County, 141 86, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nascobal nasal spray (cyanocobalamin, USP)

Drug

Single intranasal administration

Vitamin B12-ratiopharm N, injection solution

Drug

One single intramuscular administration

Primary outcomes

  1. Relative bioavailability

    Time frame: 0-72 hours

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

Secondary outcomes

  1. Additional PK characteristics

    Time frame: 0-72h

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

Sponsors and collaborators

Lead sponsor

Swedish Orphan Biovitrum

Industry

Registry information

Official study title

An Open, Randomized, Single-dose, Two-way Crossover Study to Characterize the Pharmacokinetic Properties of Cyanocobalamin When Administered as an Intranasal Spray and an Intramuscular Injection to Healthy Volunteers

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 1, 2011
Registry last updated
Nov 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.