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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06066060
Other study ID # JY-JM025-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 17, 2023
Est. completion date November 6, 2023

Study information

Verified date April 2024
Source Jemincare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date November 6, 2023
Est. primary completion date November 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
JMKX000623
JMKX000623, administered orally ;
Metformin
Metformin,administered orally

Locations

Country Name City State
China Huashan Hospital Fudan University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Jemincare

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area Under the Dosing Time Curve During the Dosing Interval After Reaching Steady State(AUC0-tau) baseline through 4 days post-dose
Primary Maximum observed After Reaching steady state concentration (Css,max) baseline through 4 days post-dose
Secondary Adverse events (AEs) Incidence and features of AEs assessed by CTCAE v5.0. baseline through 4 days post-dose
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