Bioequivalence of Fresenius Kabi USA, LLC Glucagon for SC Injection Compared to Glucagon for Injection (Bedford Laboratories)

NCT02086227 | Completed Phase 1

• 1 other identifier: GLUC-002-CP1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoglycemia

Keywords

Bioequivalence

Outcome Measures

Primary Outcomes (1)

• Glucagon and Glucose concentrations in plasma.

  Plasma samples for Glucose and Glucagon will be collected until 4 hours post dose.

Study Arms (2)

A Glucagon for Injection, Fresenius Kabi USA

EXPERIMENTAL

The subjects will be administered the test (A) (Glucagon for Injection, Fresenius Kabi USA)or reference (B) product (GlucaGen® for Injection, Bedford Laboratories) according to a two treatments, four periods replicate crossover, randomized design with two sequences (BABA and ABAB, the Left-Right site of injection for each period and treatment will be randomized.

Drug: Glucagon for Injection (Fresenius Kabi USA)

B GlucaGen® (Bedford Laboratories)

ACTIVE COMPARATOR

The subjects will be administered the test (A) Glucagon for Injection, Fresenius Kabi USA; or reference (B) product, GlucaGen® (Bedford Laboratories) according to a two treatments, four periods replicate crossover, randomized design with two sequences (BABA and ABAB, the Left-Right site of injection for each period and treatment will be randomized.

Drug: Glucagon for Injection (Bedford Laboratories)

Interventions

Glucagon for Injection (Fresenius Kabi USA) DRUG

Test product: A 1 mg (1 IU/ml) Glucagon for Injection (Fresenius Kabi USA)

Also known as: Reference product A

A Glucagon for Injection, Fresenius Kabi USA

Glucagon for Injection (Bedford Laboratories) DRUG

Reference product: B 1 mg (1 IU/ml) of GlucaGen® for Injection (Bedford Laboratories)

Also known as: Reference Product B: GlucaGen® (Bedford Laboratories)

B GlucaGen® (Bedford Laboratories)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, 18 years or older, with a body mass index (BMI) of 18- 30 kg/m2 inclusive.
• Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
• Signed and dated informed consent form, which meets all criteria of current guidelines of the Medical Research Council (MRC) of Canada and FDA regulations.
• 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.

You may not qualify if:

• If female, pregnant, lactating or likely to become pregnant during the study.
• 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.
• Significant history or current evidence of chronic infectious disease, system disorders or organ dysfunction.
• Presence of gastrointestinal disease or history of malabsorption within the last year. Any history of duodenal or gastric ulcer.
• History of psychiatric disorders occurring within the last two years that required hospitalization medication.
• Presence of a medical condition requiring regular treatment with prescription drugs.
• 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.
• Receipt of any drug as part of a research study within 30 days prior to dosing.
• Drug or alcohol addiction requiring treatment in the past 12 months.
• Donation or significant loss of whole blood (480 ml or more) within 3 months or plasma within 14 days prior to dosing.
• Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C antibody.
• Unable, or unwilling to tolerate multiple venipunctures.
• Has difficulty fasting or consuming the standard meals that will be provided.
• No prescription medications (other than contraceptives) used within 14 days prior to initial study dosing and throughout the times of sample collection each period.
• No over-the-counter medications within 14 days prior to each dosing and throughout the times of sample collection each period.

Sponsors & Collaborators

• Fresenius Kabi USA, LLC: lead

Study Sites (1)

West Houston Clinical Research Services, 2026 Wirt Road

Houston, Texas, 77055, United States

Location

MeSH Terms

Conditions

Hypoglycemia

Interventions

Glucagon; Injections

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Oscar De Valle, M.D.

  West Houston Clinical Research Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: March 13, 2014
• Study Start: May 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 13, 2014

Record last verified: 2014-03

Locations

US (1)