HypoglycemiaPhase 1NCT02086227
Bioequivalence of Fresenius Kabi USA, LLC Glucagon for SC Injection Compared to Glucagon for Injection (Bedford Laboratories)
A Phase 1 study testing Glucagon for Injection (Fresenius Kabi USA) and Glucagon for Injection (Bedford Laboratories) in people with Hypoglycemia, run by Fresenius Kabi USA, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- Glucagon for Injection (Fresenius Kabi USA) and Glucagon for Injection (Bedford Laboratories)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Houston Clinical Research Services, 2026 Wirt Road
Houston, Texas, 77055
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypoglycemia
- Being tested
- Glucagon for Injection (Fresenius Kabi USA), Glucagon for Injection (Bedford Laboratories)
- Keywords
- Bioequivalence
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon for Injection (Fresenius Kabi USA)Drug
Also called Reference product A
Test product: A 1 mg (1 IU/ml) Glucagon for Injection (Fresenius Kabi USA)
Glucagon for Injection (Bedford Laboratories)Drug
Also called Reference Product B: GlucaGen® (Bedford Laboratories)
Reference product: B 1 mg (1 IU/ml) of GlucaGen® for Injection (Bedford Laboratories)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Glucagon for Injection (Bedford Laboratories) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucagon and Glucose concentrations in plasma.
Measured: Plasma samples for Glucose and Glucagon will be collected until 4 hours post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMay 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi USA, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oscar De Valle, M.D., Principal investigator, West Houston Clinical Research Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086227
- Sponsor's protocol ID
- GLUC-002-CP1
- Status last verified
- Mar 2014
- First submitted
- 11 Mar 2014
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of a Test Formulation of Glucagon for SC Injection Compared to Glucagon for Injection (Bedford Laboratories) Under Fasted Conditions
- ClinicalTrials.gov ID
- NCT02086227
- Acronym / sponsor ID
- GLUC-002-CP1
- Conditions
- Hypoglycemia
- Keywords
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fresenius Kabi USA, LLCIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Glucagon for Injection, Fresenius Kabi USA | Experimental | Drug: 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. |
| B GlucaGen® (Bedford Laboratories) | Active comparator | Drug: Glucagon for Injection (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucagon for Injection (Fresenius Kabi USA)Also: Reference product ATest product: A 1 mg (1 IU/ml) Glucagon for Injection (Fresenius Kabi USA) | Drug | A Glucagon for Injection, Fresenius Kabi USA |
| Glucagon for Injection (Bedford Laboratories)Also: Reference Product B: GlucaGen® (Bedford Laboratories)Reference product: B 1 mg (1 IU/ml) of GlucaGen® for Injection (Bedford Laboratories) | Drug | B GlucaGen® (Bedford Laboratories) |
Primary outcome
Glucagon and Glucose concentrations in plasma.
Time frame: Plasma samples for Glucose and Glucagon will be collected until 4 hours post dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar De Valle, M.D. principal investigator
West Houston Clinical Research Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glucagon for Injection (Fresenius Kabi USA) and Glucagon for Injection (Bedford Laboratories) in people with Hypoglycemia, run by Fresenius Kabi USA, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucagon and Glucose concentrations in plasma. (time frame: Plasma samples for Glucose and Glucagon will be collected until 4 hours post dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2014.