Pharmacokinetics and safety of subcutaneous pasireotide and intramuscular pasireotide long-acting release in Chinese male healthy volunteers: a phase I, single-center, open-label, randomized study

What Was Tested

The paper reports a study of Somatostatin and Pasireotide, published as a randomized controlled trial.

Who Took Part

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

The PK parameters were assessed with noncompartmental analysis.

How the Study Was Run

In design terms this was a randomized and open-label study.

The participants were allocated by chance, so the Somatostatin group and the comparison group should start out alike.

Being open-label, the Somatostatin study did not mask who received what.

Statistical comparison of PK parameters, including AUC, Cmax, and CL/F from both formulations, was made for Chinese versus Western male HVs.

The safety profile was also assessed.

Metabolic parameters, including blood glucose, insulin, and glucagon, and measures that reflect the effects of pasireotide LAR on relatively long-term glucose control, lipid metabolism, and systemic concentrations of pancreatic enzymes and thyrotropin were evaluated.

What Was Measured

The subject headings attached to it are Asian People, Blood Glucose, China, Cholesterol, Diarrhea, Dizziness and Drug Administration Routes.

Author keywords: Chinese, healthy volunteers, long-acting release, pasireotide and subcutaneous.

What This Means in Plain Language

The paper is a randomized and open-label study of Somatostatin and Pasireotide.

The abstract goes on to report its results in about 11 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2014 (Clinical therapeutics), a journal based in United States.

More context: the Somatostatin compound page and the Pasireotide compound page, all human trials.