A DDI Study of JMKX000623 and Metformin Hydrochloride

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06066060
• Other study ID #: JY-JM025-102
• Status: Completed
• Phase: Phase 1
• Start date: September 17, 2023
• Est. completion date: November 6, 2023

Study information

• Verified date: April 2024
• Source: Jemincare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Drug-Drug Interaction
• Healthy

Intervention

Drug:
• JMKX000623
JMKX000623, administered orally ;
• Metformin
Metformin,administered orally

Locations

Country	Name	City	State
China	Huashan Hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jemincare

Country where clinical trial is conducted

China, 

Outcome

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