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

This study has been completed.
Sponsor:
Information provided by:
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT00745186
First received: September 2, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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 1

Study Type: Interventional
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.

Resource links provided by NLM:


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
Active Comparator: 1
Glucagen
Drug: Glucagen
0.2 mg or 1 mg Glucagen single injection
Experimental: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 INC Research
  More Information

No publications provided

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

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins

ClinicalTrials.gov processed this record on September 18, 2014