Study to Evaluate the Drug-drug Interaction of JMKX003142 in Healthy Subjects
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorJemincare
About this trial
To evaluate the effects of oral administration rifampicin or itraconazole capsules on the pharmacokinetics of JMKX003142 in healthy subjects.
Eligibility criteria
Qualifiers
Fully understand the research content, process, and potential risks of this trial, voluntarily participate in the clinical trial and sign the informed consent,
Healthy male and female subjects aged ≥18 years and ≤45 years old, Male weight ≥50kg, female weight ≥45kg, body mass index ≥19 kg/m2 and ≤28 kg/m2,
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.
Disqualifiers
HBV surface antigen, HCV antibody, HIV, or syphilis are positive during screening,
At the time of screening, the vital signs are within the following ranges: systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <50 mmHg or >90 mmHg, pulse <50 bpm or >100 bpm and ear temperature 37.5℃or<35℃,
More than 5 cigarettes per day during the 3 months prior to screening, Or were unable to quit smoking/containing tobacco products during the trial,
Have special requirements for diet and cannot comply with the diet provided and corresponding regulations.
Trial design
Treatments tested in this trial
- Cohort 1: JMKX003142 and itraconazole
- Cohort 2: JMKX003142 and rifampicin
Treatment groups
48 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Jemincare
Lead sponsor
Zhejiang Hangyu Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov