Open, Randomized Crossover Study on PK, PD, Biopotency, and Bioavailability of Insulin Capsules in Healthy Chinese Males
- Conditions
- Diabete Mellitus
- Interventions
- Drug: Human insulin enteric coated capsules in dose 8mgDrug: Human insulin enteric coated capsules in dose 16mgDrug: Human Insulin Injection in dose 5IU
- Registration Number
- NCT06519604
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- Brief Summary
Pharmacokinetics and pharmacodynamics study of 3 formulations (human insulin enteric coated capsules 8mg vers. human insulin injection 5IU；human insulin enteric coated capsules 16mg vers. Human Insulin Injection 5IU) Relative biopotency and bioavailability of human insulin enteric coated capsules 8mg/16mg vers. human insulin injection 5IU
- Detailed Description
An open, randomized, single dose, two-way crossover study on Pharmacokinetics, pharmacodynamics, relative biopotency and bioavailability of human insulin enteric coated capsules in healthy Chinese male subjects using hyperinsulinemic euglycemic clamp.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 20
- Healthy Chinese male subjects aged 20-35 (inclusive);
- Body mass index (BMI) between19 and 24 kg/m2 ( extrems inclusive, body mass index= body weight/ height2);
- Normal oral glucose tolerance Test (fasting plasma glucose [FPG]< 6.1 mmol/L and 2-hour postprandial blood glucose after loading with glucose [2hPG]< 7.8 mmol/L), and HbA1C<6.0%
- Normal insulin releasing test (judged by investigator);
- Considered generally healthy upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, without history of acute and chronic diseases with clinical significance, incl.: of the cardiovascular system, bronchopulmonary, neuroendocrine systems, endocrine system, as well as diseases of the gastrointestinal tract, liver, kidneys, blood, as judged by the Investigator.
- Signed informed consent and volunteers' consent to all restrictions imposed during the study.
- Known allergic or suspected hypersensitivity to investigational product (IP) or related product
- Previous or existing diseases of the cardiovascular system, endocrine system, gastrointestinal system, nervous system, or diseases of the lungs, hematologic, immunology, psychiatry, and metabolic abnormalities, as judged by the investigator;
- History of heavy smoking, alcohol abuse, and drug abuse;
- Taking more than 14 units alcohol per week within 3 months prior to screening (1unit≈360 mL of beer, 45mL of spirits, or 150 mL of wine), or receiving alcohol within 48 hours prior to IP administration, or failure to abstain from alcohol during the trial ;
- Receiving excessive amounts of tea, coffee, and/or caffeine rich beverages (8 or more cups, 1 cup ≈ 250 mL) per day within 3 months prior to screening;
- Use of any medication that may affect glucose lowering effect (such as oral contraceptives, corticosteroids, diuretics, adrenaline, salbutamol, glucagon, growth hormone, thyroid hormone, etc.) within 28 days prior to screening;
- Taking any medications, vitamin product, or any Chinese herbal medicine or nutrition supplements within 2 weeks prior to IP administration;
- Participation in any clinical trial less than 3 months prior to screening or plan to participate in other trials after ICF signed.
- Blood donation or blood loss≥ 200mL of any reasons within 3 months prior to screening; blood transfusion or component blood transfusion within 3 months prior to screening; failure to guarantee not to donate whole blood / component blood (such as plasma, platelets) during the trial or within 30 days after the end of the trial;
- Undergo surgery prior to IP administration within 1 month or plan to undergo surgery during the trial;
- Occurrence of acute disease during screening;
- Positive test of any: HIV-Ab, HBSAg, HCV-Ab,TPAb;
- history of needle phobia and blood phobia;
- Any conditions that make volunteer participation is ineligible judged by investigating physician.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Human insulin enteric coated capsules in dose 8mg Human insulin enteric coated capsules in dose 8mg Single oral administration of human insulin enteric coated capsules in dose 8mg Human insulin enteric coated capsules in dose 16mg Human insulin enteric coated capsules in dose 16mg Single oral administration of human insulin enteric coated capsules in dose 16mg. Human Insulin Injection in dose 5IU Human Insulin Injection in dose 5IU Single subcutaneous administration of Human Insulin Injection in dose 5IU
- Primary Outcome Measures
Name Time Method TGIRmax 0 -11 hours (hyperinsulinemic euglycemic clamp) PD endpoint: The time to maximum observed glucose infusion rate
AUCGIR.0-11h 0 -11 hours (hyperinsulinemic euglycemic clamp) PD endpoint: The area under the glucose infusion rate curve from 0 to 11 hours
AUCGIR0-∞ 0 -11 hours (hyperinsulinemic euglycemic clamp) PD endpoint: The area under the glucose infusion rate curve from 0 to infinity
GIRmax 0 -11 hours (hyperinsulinemic euglycemic clamp) PD endpoint: The maximum glucose infusion rate
- Secondary Outcome Measures
Name Time Method AUCIns0-11h 0 -11 hours (hyperinsulinemic euglycemic clamp) PK endpoint: The area under the insulin concentration curve from 0 to 11 hours
AUCIns0-∞ 0 -11 hours (hyperinsulinemic euglycemic clamp) PK endpoint: The area under the insulin concentration-time curve from 0 hours to infinity
Cmax 0 -11 hours (hyperinsulinemic euglycemic clamp) PK endpoint: The maximum observed insulin concentration
Tmax 0 -11 hours (hyperinsulinemic euglycemic clamp) PK endpoint: The time to maximum observed insulin concentration
Trial Locations
- Locations (1)
uijin Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China