A DDI Study of JMKX000623 and Metformin Hydrochloride

Jemincare

Status and phase: Completed; Phase 1

Conditions: Healthy; Drug-Drug Interaction

Treatments: Drug: Metformin; Drug: JMKX000623

Study type: Interventional

Funder types: Industry

Identifiers

NCT06066060

JY-JM025-102

Details and patient eligibility

About

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.

Full description

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

JMKX000623/Metformin/ JMKX000623+Metformin

Experimental group

Description:

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

Treatment:

Drug: JMKX000623

Drug: Metformin