Bioequivalence of Fresenius Kabi USA, LLC Glucagon for SC Injection Compared to Glucagon for Injection (Bedford Laboratories)
Information source: Fresenius Kabi USA, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypoglycemia
Intervention: Glucagon for Injection (Fresenius Kabi USA) (Drug); Glucagon for Injection (Bedford Laboratories) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Fresenius Kabi USA, LLC Official(s) and/or principal investigator(s):
Oscar De Valle, M.D., Principal Investigator, Affiliation: West Houston Clinical Research Services
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.
Clinical Details
Official title: Bioequivalence of a Test Formulation of Glucagon for SC Injection Compared to Glucagon for Injection (Bedford Laboratories) Under Fasted Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Glucagon and Glucose concentrations in plasma.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Males and females, 18 years or older, with a body mass index (BMI) of 18- 30 kg/m2
inclusive.
2. Good health as determined by lack of clinically significant abnormalities in health
assessments performed at screening.
3. Signed and dated informed consent form, which meets all criteria of current
guidelines of the Medical Research Council (MRC) of Canada and FDA regulations.
4. If female and of child bearing potential prepared to abstain from sexual intercourse,
use a reliable non-hormonal method of contraception during the study (e. g. condom
with spermicide, IUD). Females using hormonal contraceptives must have used the same
method for at least 28 days prior and throughout the study.
Exclusion Criteria:
1. If female, pregnant, lactating or likely to become pregnant during the study.
2. History of allergy or sensitivity to glucagon or history of any drug hypersensitivity
or intolerance which, in the opinion of the Investigator, would compromise the safety
of the subject or the study.
3. Significant history or current evidence of chronic infectious disease, system
disorders or organ dysfunction.
4. Presence of gastrointestinal disease or history of malabsorption within the last
year. Any history of duodenal or gastric ulcer.
5. History of psychiatric disorders occurring within the last two years that required
hospitalization medication.
6. Presence of a medical condition requiring regular treatment with prescription drugs.
7. Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of
inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole;
examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides,
imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days
prior to administration of the study medication.
8. Receipt of any drug as part of a research study within 30 days prior to dosing.
9. Drug or alcohol addiction requiring treatment in the past 12 months.
10. Donation or significant loss of whole blood (480 ml or more) within 3 months or
plasma within 14 days prior to dosing.
11. Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C antibody.
12. Unable, or unwilling to tolerate multiple venipunctures.
13. Has difficulty fasting or consuming the standard meals that will be provided.
14. No prescription medications (other than contraceptives) used within 14 days prior to
initial study dosing and throughout the times of sample collection each period.
15. No over-the-counter medications within 14 days prior to each dosing and throughout
the times of sample collection each period.
16. No alcohol, caffeine/xanthine or grapefruit containing food or beverages (e. g.
chocolate, coffee, tea, cola, Fresca®) ingested within 3 days prior to each dosing
and throughout the times of sample collection each period.
17. All subjects will have a saliva/urine test for drugs of abuse at check- in each study
period. Subjects with positive results will be withdrawn from the study.
18. All female subjects will be screened for pregnancy at check-in each study period with
a urine pregnancy test. Subjects with positive results will be withdrawn from the
study.
Locations and Contacts
West Houston Clinical Research Services, 2026 Wirt Road, Houston, Texas 77055, United States
Additional Information
Starting date: May 2013
Last updated: March 12, 2014
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