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

March 12, 2014 updated by: Fresenius Kabi USA, LLC

Bioequivalence of a Test Formulation of Glucagon for SC Injection Compared to Glucagon for Injection (Bedford Laboratories) Under Fasted Conditions

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77055
        • West Houston Clinical Research Services, 2026 Wirt Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A Glucagon for Injection, Fresenius Kabi USA
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)
Test product: A 1 mg (1 IU/ml) Glucagon for Injection (Fresenius Kabi USA)
Other Names:
  • Reference product A
Active Comparator: B GlucaGen® (Bedford Laboratories)
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)
Reference product: B 1 mg (1 IU/ml) of GlucaGen® for Injection (Bedford Laboratories)
Other Names:
  • Reference Product B: GlucaGen® (Bedford Laboratories)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Glucagon and Glucose concentrations in plasma.
Time Frame: Plasma samples for Glucose and Glucagon will be collected until 4 hours post dose.
Plasma samples for Glucose and Glucagon will be collected until 4 hours post dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fresenius Kabi USA, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Oscar De Valle, M.D., West Houston Clinical Research Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GLUC-002-CP1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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