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Oral Cyanocobalamin (Eligen B12) Bioavailability Study

NCT01311739 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-03-09

No results posted yet for this study

Summary

The purpose of this study is to assess and compare the pharmacokinetics (PK) of cyanocobalamin after the oral administration of Eligen® B12 (cyanocobalamin/SNAC), oral cyanocobalamin alone (commercially-available formulation) and cyanocobalamin administered intravenously (IV) (also a commercially-available formulation) to healthy male subjects under fasting conditions. The safety and tolerability of oral Eligen® B12 (cyanocobalamin/SNAC) versus oral cyanocobalamin alone and versus IV cyanocobalamin are also assessed.

Conditions

  • Healthy

Interventions

DRUG

Cyanocobalamin

Sponsors & Collaborators

  • Emisphere Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Sandra M. Connolly, MD · MDS Pharma Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Completion
2008-06-30

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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 NCT01311739 on ClinicalTrials.gov