Pharmacokinetics (PK) and Pharmacodynamics (PD) of Mayne Glucagon for Injection Compared With Glucagen® (Novo Nordisk) in Healthy Volunteers
The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics and safety of Hospira Glucagon for Injection and GlucaGen® in healthy volunteers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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.|
- Pharmacodynamics and pharmacokinetics bioequivalence [ Designated as safety issue: Yes ]
- To compare the safety of Mayne Glucagon for Injection with GlucaGen® (Novo Nordisk) in healthy volunteers [ Designated as safety issue: Yes ]
|Study Start Date:||September 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
Active Comparator: 1
0.2 mg or 1 mg Glucagen single injection
Drug: Mayne Glucagon
0.2 mg or 1 mg Mayne Glucagon
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 resonses includeing reducted or absent glucagons responses to hypoglycemia. Mayne Glucagon for Injection has been developed as an alternative to currently marketed products.
Administration of exgonous glucagon ie 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.