An interventional study of Humulin® Regular and Rinsulin® R in Bioequivalence and Therapeutic Equivalency, sponsored by Geropharm. Completed at 1 site in Russian Federation. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-22.
Sponsored by Geropharm · Not applicable, Interventional, and Basic science
Pharmacokinetics and pharmacodynamics of Rinsulin® R, injection solution, 100 IU / ml (GEROPHARM LLC, Russia) and Humulin® Regular, injection solution, 100 IU / ml (Lilly France ", France) using the euglycemic hyperinsulinemic clamp method.
A double-blind, randomized, comparative, crossover study of the pharmacokinetics and pharmacodynamics of Rinsulin® R, solution for injection, 100 IU / ml (GEROPHARM LLC, Russia) and Humulin® Regular, solution for injection, 100 IU / ml (Lilly France, France) using euglycemic hyperinsulinemic clamp method on healthy volunteers
Geropharm is the lead sponsor of 23 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
History of to heparin, insulin or any of the of the drugs.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single subcutaneous administration of Insulin at a dose 0.3 IU / kg
Drug: Humulin® Regular · Drug: Rinsulin® R
Single subcutaneous administration of Insulin at a dose 0.3 IU / kg
Drug: Humulin® Regular · Drug: Rinsulin® R
subcutaneous injection at a dose of 0.3 IU / kg
Also known as: Reference drug
subcutaneous injection at a dose of 0.3 IU / kg
Also known as: Test Drug
Смах
Drug Observed Maximum Plasma Concentration
Time frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
AUC 0-10
Total area under the curve "drug concentration - time" in the time interval from 0 to 10 h
Time frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
AUC GIR 0-12
Total area under the curve "glucose infusion rate - time" in the time interval from 0 to 12 h
Time frame: - 120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
GIRmax
Time to reach maximum glucose infusion rate
Time frame: -120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
tGIRmax
Time to reach maximum glucose infusion rate
Time frame: -120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
AUC 0-2
Total area under the curve "drug concentration - time" in the time interval from 0 to 2 h
Time frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
AUC 0-4
Total area under the curve "drug concentration - time" in the time interval from 0 to 4 h
Time frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
AUC 0-6
Total area under the curve "drug concentration - time" in the time interval from 0 to 6 h
Time frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
Tmax
Time to reach test drug Maximum Plasma Concentration
Time frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
T1/2
Half-life of a test drug
Time frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
tGIRlag
Time between the drug administration and the onset of action
Time frame: -120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
AUC GIR 0-2
Total area under the curve "glucose infusion rate - time" in the time interval from 0 to 2 h
Time frame: -120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
AUC GIR 0-4
Total area under the curve "glucose infusion rate - time" in the time interval from 0 to 4 h
Time frame: - 120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
AUC GIR 0-6
Total area under the curve "glucose infusion rate - time" in the time interval from 0 to 6 h
Time frame: -120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
Plan to share: No
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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