NCT00745186

Pharmacokinetics (PK) and Pharmacodynamics (PD) of Mayne Glucagon for Injection Compared With Glucagen® (Novo Nordisk) in Healthy Volunteers

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Hospira, now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Hypoglycemia

Interventions

Type	Name	Description
DRUG	Glucagen	0.2 mg or 1 mg Glucagen single injection
DRUG	Mayne Glucagon	0.2 mg or 1 mg Mayne Glucagon

Timeline

• Start date: 2007-08-01
• Primary completion: 2007-10-01
• Completion: 2008-03-01
• First posted: 2008-09-03
• Last updated: 2017-03-20

Locations

1 site across 1 country: United Kingdom