ADPKD (autosomal Dominant Polycystic Kidney Disease)
Conditions
Brief summary
To evaluate the effects of oral administration rifampicin or itraconazole capsules on the pharmacokinetics of JMKX003142 in healthy subjects.
Interventions
DRUGCohort 1: JMKX003142 and itraconazole
JMKX003142: Dose: 3 mg, D1, once only in the morning. 3 mg JMKX003142 coadministered with 200 mg itraconazole once: Day8, once only in the morning. Itraconazole：Dose: 200mg once；Day5-Day7 and Day9-Day11, QD
DRUGCohort 2: JMKX003142 and rifampicin
JMKX003142: Dose: 6 mg, D1, once only in the morning. 3 mg JMKX003142 coadministered with 200 mg rifampicin once: Day14, once only in the morning. Rifampicin：Dose: 600mg once；Day5-Day13 and Day15-Day17, QD
Sponsors
Zhejiang Hangyu Pharmaceutical Co., Ltd.
Jemincare
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of JMKX003142 in plasma | approximately 5 days after JMKX003142 administered | Cmax of JMKX003142 when JMKX003142 administered with or without itraconazole/rifampicin |
| AUC of JMKX003142 in plasma | approximately 5 days after JMKX003142 administered | AUC of JMKX003142 when JMKX003142 administered with or without itraconazole/rifampicin |
Contacts
Primary ContactJianping Su
Outcome results
None listed