A DDI Study of JMKX000623 and Metformin Hydrochloride

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

Official Title
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Phase I Study to Evaluate the Drug-Drug Interaction (DDI) Between JMKX000623 Tablets and Metformin Hydrochloride Tablets in Healthy Chinese Subjects

Conditions
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Healthy, Drug-Drug Interaction

Intervention / Treatment
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* Drug: JMKX000623
* Drug: Metformin
* Drug: JMKX000623
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Chinese subjects aged 18-45 years, male or female; Weight: male≥50.0kg, female≥45.0kg, 19.0 kg/m2≤BMI<27.0 kg/m2; Normal or abnormal but without clinical significance reports of physical examinations, vital signs, clinical laboratory tests and others; Able to provide written informed consent voluntarily. Exclusion Criteria: 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; History of clinically significant chronic gastrointestinal disease or history of gastrointestinal surgery (excluding appendectomy) that the investigator believes may affect drug absorption; 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; 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; Other conditions unsuitable for the study confirmed by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JMKX000623/Metformin/ JMKX000623+Metformin<br>D1-D8, JMKX000623; D14-D19, Metformin; D20-D27, JMKX000623+Metformin | Drug: JMKX000623<br>* JMKX000623, 200mg，administered orally once daily for 8 doses(D1-D8）;<br>Drug: Metformin<br>* D14-D17, Metformin, 500mg, administered orally twice daily for 7 doses(D14-D17，D17 only 1 dose at morning);<br>Drug: JMKX000623<br>* JMKX000623, 200mg, administered orally once daily for 8 doses(D20-D27）;<br>Drug: Metformin<br>* Metformin, 500mg, administered orally twice daily for 7 doses(D24-D27，D27 only 1 dose at morning);<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Dosing Time Curve During the Dosing Interval After Reaching Steady State（AUC0-tau） |  | baseline through 4 days post-dose | 
| Maximum observed After Reaching steady state concentration (Css,max) |  | baseline through 4 days post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) | Incidence and features of AEs assessed by CTCAE v5.0. | baseline through 4 days post-dose |