A DDI Study of JMKX000623 and Metformin Hydrochloride

NCT ID: NCT06066060

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-17
• Study Completion Date: 2023-11-06

Brief Summary

A phase 1, single center, 1 sequence, 3 period, open label, multiple doses study to evaluate the drug-drug interaction of JMKX000623 tablet and metformin.

Detailed Description

The drug-drug interaction study is meant to evaluate the pharmacokinetics and safety of JMKX000623 tablet combined metformin in healthy volunteers

Conditions

Healthy; Drug-Drug Interaction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

JMKX000623/Metformin/ JMKX000623+Metformin

D1-D8, JMKX000623; D14-D19, Metformin; D20-D27, JMKX000623+Metformin

Group Type: EXPERIMENTAL

JMKX000623

Intervention Type: DRUG

JMKX000623, administered orally ;

Metformin

Intervention Type: DRUG

Metformin,administered orally

Interventions

JMKX000623

JMKX000623, administered orally ;

Intervention Type: DRUG

Metformin

Metformin,administered orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy Chinese subjects aged 18-45 years, male or female;

2. Weight: male≥50.0kg, female≥45.0kg, 19.0 kg/m2≤BMI<27.0 kg/m2;

3. Normal or abnormal but without clinical significance reports of physical examinations, vital signs, clinical laboratory tests and others;

4. Able to provide written informed consent voluntarily.

Exclusion Criteria

1. Suspected hypersensitivity to the main ingredients and excipients of JMKX000623 tablets, metformin hydrochloride tablets, or a history of allergy to drugs, food or other substances;

2. History of clinically significant chronic gastrointestinal disease or history of gastrointestinal surgery (excluding appendectomy) that the investigator believes may affect drug absorption;

3. Surgery within 3 months prior to screening that, in the judgment of the investigator, would interfere with the absorption, distribution, metabolism, or excretion of the drug, or surgery within 4 weeks prior to the use of the investigational drug, or planned surgery during the research;

4. Took any prescription, over-the-counter, and herbal medications within 2 weeks prior to screening, or were within 5 half-lives of the medication at the time of screening, and plan to take other experimental medications other than those in this study for the duration of the research;

5. Other conditions unsuitable for the study confirmed by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jemincare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaojie Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

JY-JM025-102

Identifier Type: -

Identifier Source: org_study_id