A DDI Study of JMKX000623 and Metformin Hydrochloride

Jemincare (Industry)
Overall Status
Active, not recruiting
CT.gov ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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

Study Design

Study Type:
Anticipated Enrollment :
24 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Phase I Study to Evaluate the Drug-Drug Interaction (DDI) Between JMKX000623 Tablets and Metformin Hydrochloride Tablets in Healthy Chinese Subjects
Actual Study Start Date :
Sep 17, 2023
Anticipated Primary Completion Date :
Oct 21, 2023
Anticipated Study Completion Date :
Oct 21, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: JMKX000623/Metformin/ JMKX000623+Metformin

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

Drug: JMKX000623
JMKX000623, 200mg,administered orally once daily for 8 doses(D1-D8);

Drug: Metformin
D14-D17, Metformin, 500mg, administered orally twice daily for 7 doses(D14-D17,D17 only 1 dose at morning);

Drug: JMKX000623
JMKX000623, 200mg, administered orally once daily for 8 doses(D20-D27);

Drug: Metformin
Metformin, 500mg, administered orally twice daily for 7 doses(D24-D27,D27 only 1 dose at morning);

Outcome Measures

Primary Outcome Measures

  1. Area Under the Dosing Time Curve During the Dosing Interval After Reaching Steady State(AUC0-tau) [baseline through 4 days post-dose]

  2. Maximum observed After Reaching steady state concentration (Css,max) [baseline through 4 days post-dose]

Secondary Outcome Measures

  1. Adverse events (AEs) [baseline through 4 days post-dose]

    Incidence and features of AEs assessed by CTCAE v5.0.

Eligibility Criteria


Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 Huashan Hospital Fudan University Shanghai Shanghai China

Sponsors and Collaborators

  • Jemincare


  • Principal Investigator: Xiaojie Wu, MD, Huashan Hospital

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • JY-JM025-102
First Posted:
Oct 4, 2023
Last Update Posted:
Oct 4, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 4, 2023