NCT02086227

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

Bioequivalence of a Test Formulation of Glucagon for SC Injection Compared to Glucagon for Injection (Bedford Laboratories) Under Fasted Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Fresenius Kabi USA, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Hypoglycemia

Interventions

Type	Name	Description
DRUG	Glucagon for Injection (Fresenius Kabi USA)	Test product: A 1 mg (1 IU/ml) Glucagon for Injection (Fresenius Kabi USA)
DRUG	Glucagon for Injection (Bedford Laboratories)	Reference product: B 1 mg (1 IU/ml) of GlucaGen® for Injection (Bedford Laboratories)

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2014-03-13
• Last updated: 2014-03-13

Locations

1 site across 1 country: United States