Drug-Drug Interaction, Healthy
Conditions
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
Interventions
DRUGJMKX000623
JMKX000623, administered orally ;
DRUGMetformin
Metformin,administered orally
Sponsors
Jemincare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | baseline through 4 days post-dose | Incidence and features of AEs assessed by CTCAE v5.0. |
Countries
China
Outcome results
None listed