Hypoglycemia Clinical Trial
Official title:
A Randomized, Open Label, Four Way Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety After Intramuscular (IM) Administration of Mayne Glucagon for Injection With Glucagen® (Novo Nordisk) in Healthy Volunteers.
The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamic bioequivalence and safety of Hospira Glucagon for Injection and GlucaGen® in healthy volunteers.
Glucagon has been shown to be effective in the treatment of hypoglycemia, low blood sugar
levels, in patients with diabetes. It primarily functions as a counter-regulatory hormone by
opposing the actions of insulin to maintain blood glucose levels. A major problem for
diabetic patients with hypoglycemia is the development of defective counter regulatory
responses including reduced or absent glucagon responses to hypoglycemia. Mayne Glucagon for
Injection has been developed as an alternative to currently marketed products.
Administration of exogenous glucagon i.e., not produced in the body, has been shown to be
effective in the treatment of low blood sugar in patients with diabetes. Mayne has developed
a product, Glucagon for Injection, which is an alternative to currently marketed products.
The only difference is the source of the active ingredient. The formulation, routes of
administration, dosage regimen and indications of Mayne Glucagon for Injection are identical
to those currently registered for the marketed product.
A total of 28 healthy volunteers will be recruited into this study at one investigational
site.
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