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

NCT ID: NCT06901726

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2025-06-01

Brief Summary

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

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Human insulin enteric coated capsules in dose 32mg

Single oral administration of human insulin enteric coated capsules in dose 32mg.

Group Type: EXPERIMENTAL

Human insulin enteric coated capsules in dose 32mg

Intervention Type: DRUG

Single oral administration of human insulin enteric coated capsules in dose 32mg (16 mg per capsule, two capsules).

Human Insulin Injection in dose 5 IU

Single subcutaneous administration of Human Insulin Injection in dose 5IU.

Group Type: ACTIVE_COMPARATOR

Human Insulin Injection in dose 5IU

Intervention Type: DRUG

Single subcutaneous administration of Human Insulin Injection in dose 5IU.

Interventions

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).

Intervention Type: DRUG

Human Insulin Injection in dose 5IU

Single subcutaneous administration of Human Insulin Injection in dose 5IU.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy Chinese male subjects aged 20-35 (inclusive);

2. Body mass index (BMI) between 19 and 24 kg/m2 ( extrems inclusive, body mass index= body weight/ height2);

3. 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%

4. Normal insulin releasing test (judged by investigator);

5. 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.

6. Signed informed consent and volunteers' consent to all restrictions imposed during the study.

Exclusion Criteria

1. Known allergic or suspected hypersensitivity to investigational product (IP) or related product

2. 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;

3. History of heavy smoking, alcohol abuse, and drug abuse;

4. 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;

5. 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;

6. 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;

7. Taking any medications, vitamin products, or any Chinese herbal medicine or nutrition supplements within 2 weeks prior to IP administration;

8. Participation in any clinical trial less than 3 months prior to screening or planning to participate in other trials after ICF signed.

9. 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;

10. Undergo surgery prior to IP administration within 1month or plan to undergo surgery during the trial;

11. Occurrence of acute disease during screening;

12. Positive test of any: HIV-Ab, HBSAg, HCV-Ab,TP-Ab;

13. History of needle phobia and blood phobia;

14. Any conditions that make volunteer participation ineligible judged by investigating physician.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Wang Weiqing

Professor, PHD, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Yifei Zhang, MD, PHD

Role: CONTACT

feifei-a@163.com

+86-13524640378

Weiqing Wang, MD, PHD

Role: CONTACT

wqingw@shsmu.edu.cn

+86-64370045

Other Identifiers

ORA-H-CN-008

Identifier Type: -

Identifier Source: org_study_id