Bioequivalence Study of INS062 and Pharmacokinetics and Pharmacokinetics Study of Single Injection of HR20014 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-05

Study Completion Date

2023-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was divided into two parts. The aim of this study is to investigate the bioequivalence of INS062 injection andNovoRapid ® in healthy subjects(Part I), and to investigate the pharmacokinetics and pharmacodynamics of single dose of HR20014 injection and BIAsp 30 in healthy subjects(Part II).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Beta Cell Function and Related Pharmacodynamics of HMS5552 in T2DM Patients

NCT02386982

Type 2 Diabetes

COMPLETED PHASE1

Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes

NCT01697618

Diabetes Diabetes Mellitus, Type 2

COMPLETED PHASE2

Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Japanese Subjects

NCT01527630

Diabetes Diabetes Mellitus, Type 2

COMPLETED PHASE1

A Study to Evaluate the Pharmacokinetics and Safety of BR3409 and Co-administration of BR3409-1 and BR3409-2 in Healthy Volunteers Under Fed Conditions

NCT06879132

Type 2 Diabetes

COMPLETED PHASE1

Investigating Efficacy and Safety of Biphasic Insulin Aspart 50 Twice Daily Versus Biphasic Human Insulin 50 Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus

NCT01892020

Diabetes Diabetes Mellitus, Type 2

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

INS062

Group Type EXPERIMENTAL

INS062 injection

Intervention Type DRUG

Part I: A single dose of 1.2noml/kg is administered.

NovoRapid ®

Group Type ACTIVE_COMPARATOR

Insulin Aspart

Intervention Type DRUG

Part I: A single dose of 0.2U/kg is administered.

HR20014

Group Type EXPERIMENTAL

HR20014 injection

Intervention Type DRUG

Part II: Ascending single doses at three dose levels

BIAsp 30

Group Type ACTIVE_COMPARATOR

Insulin Aspart 30 Injection

Intervention Type DRUG

Part II: A single dosewas administered

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

INS062 injection

Part I: A single dose of 1.2noml/kg is administered.

Intervention Type DRUG

Insulin Aspart

Part I: A single dose of 0.2U/kg is administered.

Intervention Type DRUG

HR20014 injection

Part II: Ascending single doses at three dose levels

Intervention Type DRUG

Insulin Aspart 30 Injection

Part II: A single dosewas administered

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male subjects aged 18 \~ 45 (including the boundary. value)(Part I). Subjects aged 18 \~ 45 (including the boundary value), male or female(Part II).
2. Subjects who are considered to be generally healthy, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
3. Body Mass Index (BMI) between 18.0-26.0 kg/m2 (both inclusive).

Exclusion Criteria

1. A history of recurrent or severe drug food allergy, or known or suspected allergy to any component of the study drug.
2. Have a history of hypertension.
3. Severe systemic infectious diseases within 1 month before screening.
4. Use of prescription drugs (topical eye/nasal drops and creams and occasional antipyretic and analgesic drugs such as acetaminophen within recommended doses are permitted) and over-the-counter drugs, and Chinese herbal medicine (regular vitamins are allowed) within 2 weeks before screening.
5. Presence of any abnormal and clinically significant laboratory tests.
6. 12-lead electrocardiogram (ECG) showed abnormal and clinically significant.
7. Known or suspected history of drug abuse or positive urine drug screening test within screening period.
8. Those who have participated in any drug clinical trials within 3 months or 5 half-life periods before screening (The elder shall prevail), who participated in clinical trials are defined as random, prior to screening;
9. Women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential (WOCBP) are reluctant to use appropriate contraception during the trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes