Healthy Clinical Trial
Official title:
Phase I Study to Evaluate the Drug-Drug Interaction (DDI) Between JMKX000623 Tablets and Metformin Hydrochloride Tablets in Healthy Chinese Subjects
Verified date | April 2024 |
Source | Jemincare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Huashan Hospital Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Jemincare |
China,
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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