Open, Randomized Crossover Study on PK, PD, Biopotency, and Bioavailability of Insulin Capsules in Healthy Chinese Males

Официальное название

An Open, Randomized, Single Dose (32mg), Two-way Crossover Study on Pharmacokinetics, Pharmacodynamics, Relative Biopotency and Bioavailability of Human Insulin Enteric Coated Capsules in Healthy Chinese Male Subjects

Обзор

Pharmacokinetics and pharmacodynamics study of 2 formulations (human insulin enteric coated capsules 32mg vs. human insulin injection 5IU) Relative biopotency and bioavailability of human insulin enteric coated capsules 32mg vs. human insulin injection 5IU

Подробное описание

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.

Вмешательства

• Препарат Human insulin enteric coated capsules in dose 32mg
  Single oral administration of human insulin enteric coated capsules in dose 32mg (16 mg per capsule, two capsules).
• Препарат Human Insulin Injection in dose 5IU
  Single subcutaneous administration of Human Insulin Injection in dose 5IU.

Первичные конечные точки

• GIRmax [Срок оценки: 0-11 hours (hyperinsulinemic-euglycemic clamp)]
• TGIRmax [Срок оценки: 0-11 hours (hyperinsulinemic-euglycemic clamp)]
• AUCGIR 0-11h [Срок оценки: 0-11 hours (hyperinsulinemic-euglycemic clamp)]
• AUCGIR0-∞ [Срок оценки: 0-11 hours (hyperinsulinemic-euglycemic clamp)]

Вторичные конечные точки (4)

• Cmax [Срок оценки: 0-11 hours (hyperinsulinemic-euglycemic clamp)]
• Tmax [Срок оценки: 0-11 hours (hyperinsulinemic-euglycemic clamp)]
• AUCIns0-11h [Срок оценки: 0-11 hours (hyperinsulinemic-euglycemic clamp)]
• AUCIns0-∞ [Срок оценки: 0-11 hours (hyperinsulinemic-euglycemic clamp)]

Критерии участия

Критерии включения

• Healthy Chinese male subjects aged 20-35 (inclusive);
• Body mass index (BMI) between 19 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.

Критерии исключения

• 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 products, 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 planning to participate in other trials after ICF signed.
• Blood donation or blood loss≥ 200mL of any reasons within 3 months prior to screening; history of blood transfusion or component blood transfusion; 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 1month or plan to undergo surgery during the trial;
• Occurrence of acute disease during screening;
• Positive test of any: HIV-Ab, HBSAg, HCV-Ab,TP-Ab;
• History of needle phobia and blood phobia;
• Any conditions that make volunteer participation ineligible judged by investigating physician.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06901726 · ORA-H-CN-008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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