Healthy Volunteers
Conditions
Brief summary
The primary objective of this study was to assess the effect of rifampicin and itraconazole, on the pharmacokinetics (PK) of Jaktinib in healthy Volunteers.
Interventions
Oral Jaktinib 100 mg for 1 day
Oral Itraconazole 200 mg for 9 day
Oral Rifampicin 600 mg for 11 day
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Volunteers aged between 18 and 45 years old; * Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) between 19 and 28 (including 19 and 28); * The participant is in good health and has no history of heart, liver, kidney, digestive tract, nervous system, etc.;
Exclusion criteria
* The participant were deemed unsuitable for participating in the study by the investigator for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Up to 32 Days | Pharmacokinetics of Jaktinib by assessment of maximum plasma concentration |
| AUC | Up to 32 Days | Area under the plasma concentration versus time curve (AUC) of Jaktinib |
| Adverse Events | Up to 32 Days | Number of Participants With treatment-related Adverse Events and Serious Adverse Events |
Countries
China
Outcome results
None listed