This investigation will serve as a basis for Fresenius Kabi USA, to obtain regulatory approval of a synthetic version of Glucagon (Fresenius Kabi USA), 1 mg (1 IU), SC. The aim is to conduct direct comparative pharmacokinetics and pharmacodynamics of 1 mg (1 IU) of synthetic Glucagon (Fresenius Kabi USA) with that of GlucaGen® (manufactured by Novo Nordisk A/S, marketed by Bedford Laboratories), 1 mg (1 IU), SC in healthy adult subjects. This study will examine a comparison of the bioavailability pharmacokinetics of 1 mg (1 IU) of Glucagon (Fresenius Kabi USA) by having each subject receive in each period either a single dose of 1 mg (1 IU) of Glucagon (Fresenius Kabi USA) or a single dose of GlucaGen® (Bedford Laboratories), 1 mg (1 IU), via subcutaneous injection. Blood samples will be collected three (3) times starting 2 hours prior to dosing and at intervals over 4 hours post dose. The concentrations of glucagon and glucose will be measured.
The primary objective of this study is to ascertain the pharmacokinetics (PK) and pharmacodynamics (PD) bioequivalence of a subcutaneous (SC) injection of 1 mg (1 IU) of Glucagon (Fresenius Kabi USA) in comparison to the reference product, GlucaGen® (Bedford Laboratories), 1 mg (1 IU), SC in healthy adult subjects.