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NCT07181265Not yet recruitingPhase 1

Drug-Drug Interaction of JMKX003142 With Amiodarone and Febuxostat in Healthy Subjects

A Single-center, Non-randomized, Open-label, Self-controlled Phase I Drug-drug Interaction Clinical Study to Evaluate the Pharmacokinetics of JMKX003142 With Amiodarone, and Febuxostat in Chinese Healthy Subjects

Source: ClinicalTrials.gov · Last updated 18 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This is a open-label, non-randomized, multiple oral dosings, three-period, drug-drug interaction study of JMKX003142 tablet, Amiodarone Hydrochloride Tablets and Febuxostat Tablets in Chinese healthy adult subjects

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
48 (estimated)
First submitted
12 Sept 2025
Start date
30 Oct 2025
Primary completion date
30 Apr 2026
Lead sponsor
Jemincare
NCT number
NCT07181265

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 48
  • From 30 Oct 2025 to the primary completion date, 30 Apr 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Subjects having hypersensitivity to study drug or have a history of allergies to multiple drugs, foods, or other substances
  • History or presence of significant circulatory system, respiratory system, digestive system, blood system, urinary and reproductive system, endocrine and metabolic system, nervous system, mental system, muscular and skeletal system, skin system, lymphatic system, immune system, Otolaryngology or other related systems disease or disorder. as well as systemic or local acute or chronic infections.
  • Subjects with dysphagia, gastrointestinal diseases, or any conditions that may affect drug absorption; such as a history of hepatobiliary and pancreatic diseases, gastrointestinal diseases, gastrointestinal surgery (except appendectomy), or a history of chronic pancreatitis, idiopathic acute pancreatitis, or habitual diarrhea.
  • Vital signs during the screening period meet any of the following conditions: systolic blood pressure \>140 mmHg or \<90 mmHg; diastolic blood pressure \>90 mmHg or \<50 mmHg (Cohort 1: diastolic blood pressure \>90 mmHg or \<60 mmHg); pulse \>100 beats/min or \<50 beats/min (Cohort 1: pulse \>100 beats/min or \<60 beats/min); ear temperature \>37.5°C or \<35°C.

Lab values

  • History of QTc interval prolongation or abnormal ECG results during screening, QTcF ≥ 450 ms for males or ≥ 470 ms for females, or QRS interval \> 120 ms.

Who the study is looking for

  • Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.
  • Healthy adult males and/or females, 18 to 45 years of age (inclusive) at the date of signed consent form. Body mass index (BMI) greater than or equal to 18 and less than 32 (kg/m2) and a minimum body weight of 45 kg.
  • The health of the subjects was determined by the investigator based on medical history, physical examination, clinical laboratory examination, and 12-lead electrocardiogram, all of which were determined by the investigator to be normal or not clinically significant.
  • Women of child-bearing potential and sexually active males willing to use highly effective methods of contraception from screening until 3 months after last dose of study drug. In addition, participants must not donate sperm/egg for the time period specified above.

Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.