- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04184466
A Study to Compare Pharmacokinetics and Pharmacodynamics of Insulin Aspart to NovoRapid® Penfill® in Healthy Subjects
November 29, 2019 updated by: Geropharm
A Randomized Double Blinded Two-way Crossover Single-dose Pharmacokinetics and Pharmacodynamics Study of Insulin Aspart (LLC "GEROPHARM", Russia) Versus NovoRapid® Penfill® (Novo Nordisk) in Healthy Subjects Using the Euglycemic Clamp Technique
Pharmacokinetics and pharmacodynamics study of 2 formulations of insulin aspart (Insulin Aspart GEROPHARM vers.
NovoRapid® Penfill® Novo Nordisk)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A randomized double blinded two-way crossover single-dose pharmacokinetics and pharmacodynamics study of Insulin Aspart (LLC "GEROPHARM", Russia) versus NovoRapid® Penfill® (Novo Nordisk) in normal healthy subjects using the euglycemic clamp technique
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
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
-
-
-
Moscow, Russian Federation, 117036
- Endocrinology Research Centre
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Saint Petersburg,, Russian Federation, 197341
- Almazov National Medical Research Centre
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-
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
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Signed informed consent.
- Caucasian males having a confirmed healthy diagnosis as per data of standard clinical, laboratory, and instrumental examination methods.
- Age of 18-45 (both incl.).
- Body mass index equal to 18.5-30.0 kg/m2, body weight equal to 55.0-100.0 kg (both incl.).
- Volunteers' consent to all restrictions imposed during the study, including adequate methods of contraception.
- Russian citizenship.
Exclusion Criteria:
- Weighed allergic anamnesis.
- Increased sensitivity in the history of heparin, insulin or any of the excipients of the study drugs.
Any acute and chronic diseases, incl.:
- of the cardiovascular system, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.
- positive tests: hepatitis B (Ag), hepatitis C (Ab), HIV (Ab), syphilis (Ab).
- 10% deviation from references in lab tests.
- Abnormalities of the ECG and deviations in basic vital signs from the norms (screening).
- Episodes of hypoglycemia in the anamnesis; the presence in the family history of cases of a verified diagnosis of diabetes mellitus in the immediate family.
- Fasting plasma glucose> 6.1 mmol / L.
- HbA1C> 6% (screening).
- Oral glucose tolerance test - blood glucose level ≥ 7.8 mmol / l (2 hours after loading with glucose).
- Deep vein thrombosis of lower extremities in a history of life or in a family history.
- Any diet (vegetarian, etc.) extreme physical exercise, night shift work.
- Taking medications, phytopreparations, biologically active supplements less than 14 days before screening.
- History of significant drugs abuse conditions for 3 years prior to screening.
- Significant blood loss less than 3 months before the screening.
- Recovery after surgery process; scheduled surgery.
- Mental, physical and other reasons that do not allow to adequately assess their behavior and properly fulfill the conditions of the research protocol, including psychiatric disorders.
- A positive test for the content of drugs in the urine (screening)
- Receiving more than 10 units. alcohol per week (1 unit of alcohol is equivalent to 0.5 liters of beer, 200 ml of wine or 50 ml of strong alcohol) or anamnestic information about alcoholism.
- Positive test for alcohol content in the exhaled air.
- Nicotine dependence (use of tobacco less than 6 months before the start of screening).
- Presence of oncology disease in the anamnesis 5 years prior the start of screening.
- Participation in a clinical trial of any medications less than 3 months or 5 half-lives before the IP administration.
- Any conditions that make it difficult, according to the informed opinion of the investigating physician, that volunteer participation in studies.
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: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Insulin Aspart
Single subcutaneous administration of Insulin Aspart in dose 0.3 IU / kg
|
insulin aspart in doses 0.3 IU/kg
|
ACTIVE_COMPARATOR: NovoRapid® Penfill®
Single subcutaneous administration of NovoRapid® Penfill® in dose 0.3 IU / kg
|
insulin aspart in doses 0.3 IU/kg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC(0-t)
Time Frame: -60, -30, 0 minutes (pre-dose) and 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 135, 150, 165, 240, 300, 360, 420 and 480 minutes post-dose
|
Pharmacokinetics of insulin aspart by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
|
-60, -30, 0 minutes (pre-dose) and 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 135, 150, 165, 240, 300, 360, 420 and 480 minutes post-dose
|
Cmax
Time Frame: -60, -30, 0 minutes (pre-dose) and 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 135, 150, 165, 240, 300, 360, 420 and 480 minutes post-dose
|
Pharmacokinetics of insulin aspart by Assessment of Observed Maximum Plasma Concentration (Cmax)
|
-60, -30, 0 minutes (pre-dose) and 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 135, 150, 165, 240, 300, 360, 420 and 480 minutes post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ACTUAL)
October 18, 2018
Primary Completion (ACTUAL)
December 19, 2018
Study Completion (ACTUAL)
December 19, 2018
Study Registration Dates
First Submitted
November 29, 2019
First Submitted That Met QC Criteria
November 29, 2019
First Posted (ACTUAL)
December 3, 2019
Study Record Updates
Last Update Posted (ACTUAL)
December 3, 2019
Last Update Submitted That Met QC Criteria
November 29, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASPART-CL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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