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

Purpose

The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics and safety of Hospira Glucagon for Injection and GlucaGen® in healthy volunteers.

Condition	Intervention	Phase
Hypoglycemia	Drug: Glucagen Drug: Mayne Glucagon	Phase I

MedlinePlus related topics:

Hypoglycemia

Drug Information available for:

Glucagon Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

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.

Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:

Pharmacodynamics and pharmacokinetics bioequivalence [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To compare the safety of Mayne Glucagon for Injection with GlucaGen® (Novo Nordisk) in healthy volunteers [ Designated as safety issue: Yes ]

Enrollment:	28
Study Start Date:	September 2007
Study Completion Date:	March 2008
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Glucagen	Drug: Glucagen 0.2 mg or 1 mg Glucagen single injection
2: Experimental Mayne Glucagon	Drug: Mayne Glucagon 0.2 mg or 1 mg Mayne Glucagon

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 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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female aged 18-50 years inclusive
Body weight between 50 - 100kg and body mass index between 18 and 30 kg/m2
Non-smokers or ex-smokers who have not smoked within the previous 3 months
Adequate method of contraception during the study and for 12 weeks after the last dose of investigational medicinal product

Exclusion Criteria:

History or presence of clinical significant gastrointestinal pathology or symptoms, liver or kidney disease or any condition that might interfere with the absorption, distribution, metabolism or excretion of the drug.
Clinically significant abnormalities in ECG results
Clinically significant laboratory findings
Positive pregnancy test or lactation
Participation in any other clinical study within the previous 12 weeks
Positive HIV, Hepatitis B or Hepatitis C test
History of drug or alcohol abuse within the past two years
Blood donation of more than 500 mL in the previous 12 weeks
Hypersensitivity to glucagons and/or any excipients
Use of specified medicines

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745186

Locations


United Kingdom
	Charles River Laboratories
	Edinburgh, United Kingdom, EH14 4AP

Sponsors and Collaborators

Hospira, Inc.

Investigators


Principal Investigator:	Stuart Mair	Kendle International

More Information

Responsible Party:	Hospira ( Rodeina Challand )
Study ID Numbers:	GLC061
First Received:	September 2, 2008
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00745186
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Naphazoline

Oxymetazoline

Metabolic Diseases

Guaifenesin

Phenylephrine

Glucagon

Phenylpropanolamine

Healthy

Metabolic disorder

Glucose Metabolism Disorders

Hypoglycemia

Additional relevant MeSH terms:

Therapeutic Uses

Physiological Effects of Drugs

Gastrointestinal Agents

Hormones, Hormone Substitutes, and Hormone Antagonists

Hormones

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Hospira, Inc.
Information provided by:	Hospira, Inc.
ClinicalTrials.gov Identifier:	NCT00745186