Bioequivalence of Fresenius Kabi USA, LLC Glucagon for SC Injection Compared to Glucagon for Injection (Bedford Laboratories)

What Was Tested

This registered phase 1 trial tested Glucagon.

It had two arms (groups): one (experimental) and B GlucaGen® (Bedford Laboratories) (active comparator).

The registry classes the interventions as drug.

More on the Plan

The concentrations of glucagon and glucose will be measured.

Who Took Part

The registry lists 32 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Males and females, 18 years or older, with a body mass index (BMI) of 18- 30 kg/m2 inclusive. Signed and dated informed consent form, which meets all criteria of current guidelines of the Medical Research Council (MRC) of Canada and FDA regulations.

The full record lists 4 inclusion and 18 exclusion criteria; among the exclusions: if female, pregnant, lactating or likely to become pregnant during the study; presence of gastrointestinal disease or history of malabsorption within the last year. any history of duodenal or gastric ulcer; history of psychiatric disorders occurring within the last two years that required hospitalization medication.

How the Study Was Run

The set-up was randomized, crossover and single-blind.

Random assignment meant chance, not the researchers, decided who got Glucagon and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Glucagon and the comparison in turn, acting as their own control.

In this single-blind Glucagon study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2013-05 with completion listed for 2013-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Glucagon and Glucose concentrations in plasma.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 32 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glucagon compound page, all human trials.