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Completed

NCT Number: NCT06066060

A DDI Study of JMKX000623 and Metformin Hydrochloride

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JMKX000623

Drug

JMKX000623, administered orally ;

metformin

Drug

Metformin,administered orally

Primary outcomes

  1. Area Under the Dosing Time Curve During the Dosing Interval After Reaching Steady State(AUC0-tau)

    Time frame: baseline through 4 days post-dose

  2. Maximum observed After Reaching steady state concentration (Css,max)

    Time frame: baseline through 4 days post-dose

Secondary outcomes

  1. Adverse events (AEs)

    Time frame: baseline through 4 days post-dose

    Incidence and features of AEs assessed by CTCAE v5.0.

Sponsors and collaborators

Lead sponsor

Jemincare

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 4, 2023
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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