Hypoglycemia Clinical Trial
Official title:
Bioequivalence of a Test Formulation of Glucagon for SC Injection Compared to Glucagon for Injection (Bedford Laboratories) Under Fasted Conditions
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.
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. ;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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