NCT01311739

Oral Cyanocobalamin (Eligen B12) Bioavailability Study

An Open-label, Single-Dose, Parallel-Group, Randomized Study of Comparative Bioavailability of B12 After Oral Administration of B2 Formulated With an Absorption Promoter (SNAC), Oral B12 Alone and IV B12 in Healthy Male Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Emisphere Technologies, Inc. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Cyanocobalamin

Timeline

• Start date: 2008-05-01
• Completion: 2008-06-01
• First posted: 2011-03-09
• Last updated: 2011-03-09