A DDI Study of JMKX000623 and Metformin Hydrochloride
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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);
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Outcome Measures
Primary Outcome Measures
- 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
- Adverse events (AEs) [baseline through 4 days post-dose]
Incidence and features of AEs assessed by CTCAE v5.0.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy Chinese subjects aged 18-45 years, male or female;
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Weight: male≥50.0kg, female≥45.0kg, 19.0 kg/m2≤BMI<27.0 kg/m2;
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Normal or abnormal but without clinical significance reports of physical examinations, vital signs, clinical laboratory tests and others;
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Able to provide written informed consent voluntarily.
Exclusion Criteria:
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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;
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History of clinically significant chronic gastrointestinal disease or history of gastrointestinal surgery (excluding appendectomy) that the investigator believes may affect drug absorption;
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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;
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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;
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Other conditions unsuitable for the study confirmed by the investigator.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Huashan Hospital Fudan University | Shanghai | Shanghai | China |
Sponsors and Collaborators
- Jemincare
Investigators
- Principal Investigator: Xiaojie Wu, MD, Huashan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JY-JM025-102