Pharmacokinetics of oral cyanocobalamin formulated with sodium N-[8-(2-hydroxybenzoyl)amino]caprylate (SNAC): an open-label, randomized, single-dose, parallel-group study in healthy male subjects

What Was Tested

This randomized controlled trial paper looks at Cyanocobalamin (Vitamin B12).

This was the first clinical study conducted with the cyanocobalamin/SNAC coformulation.

Why It Was Studied

Vitamin B12 (cobalamin) deficiency may be caused by inadequate dietary intake of B12 or by conditions that result in malabsorption of the vitamin.

Crystalline vitamin B12, usually in the form of cyanocobalamin, is administered parenterally (ie, intramuscularly) or orally for treating deficiency states.

Who Took Part

By PubMed's age tags, the people studied were young adults, adults and middle-aged adults, men only.

Vitamin B12 absolute bioavailability estimates were calculated between the oral (A, B, and C) and IV (D) treatments using non-baseline-adjusted vitamin B12 concentrations as well as baseline-adjusted vitamin B12 concentrations, with or without body weight adjustments.

How the Study Was Run

The design is described as randomized, open-label and parallel-group.

The participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

Everyone knew when Cyanocobalamin (Vitamin B12) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Human serum B12 was analyzed by chemiluminescence assay method.

Validation procedures established that samples could be diluted up to 100 times without any effects on accuracy and precision.

Tolerability was evaluated through review or monitoring of medical history, physical examination findings, concomitant medications, vital signs, laboratory tests (hematology, serum chemistry, and urinalysis values), electrocardiography, adverse events, and serious adverse events.

What Was Measured

The subject headings attached to it are Area Under Curve, Biological Availability, Caprylates, Drug Carriers, Feasibility Studies, Tablets and Vitamin B 12.

What This Means in Plain Language

The paper is a randomized, open-label and parallel-group study of Cyanocobalamin (Vitamin B12).

Its findings take up roughly 9 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2011 (Clinical therapeutics), a journal based in United States.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.