Phase I Study to Evaluate the Drug-Drug Interaction (DDI) Between JMKX000623 Tablets and Metformin Hydrochloride Tablets in Healthy Chinese Subjects

Jemincare1 site in 1 country24 target enrollmentSeptember 17, 2023

ConditionsHealthy Drug-Drug Interaction

InterventionsJMKX000623 Metformin

DrugsJMKX000623 Metformin

Overview

Phase: Phase 1
Intervention: JMKX000623
Conditions: Healthy
Sponsor: Jemincare
Enrollment: 24
Locations: 1
Primary Endpoint: Area Under the Dosing Time Curve During the Dosing Interval After Reaching Steady State（AUC0-tau）
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

September 17, 2023

End Date

November 6, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jemincare

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.