Status:
COMPLETED
A DDI Study of JMKX000623 and Metformin Hydrochloride
Lead Sponsor:
Jemincare
Conditions:
Healthy
Drug-Drug Interaction
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06066060
Start Date
September 17 2023
End Date
November 6 2023
Last Update
April 25 2024
Active Locations (1)
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1
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China