Myelofibrosis
Conditions
Brief summary
To evaluate the pharmacokinetic Characteristics of two formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers
Interventions
Orally, one tablet at a time
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 18≤ age ≤ 45, male or female; * Body weight: ≥50 kg for male, ≥45 kg for female; body mass index (BMI): 19.0-26.0 kg/m\^2 (inclusive); * Informed consent will be signed before the trial, and the content, process and possible adverse reactions of the trial will be fully understood; * The volunteers should be able to communicate well with the researchers and understand and comply with the requirements of the study.
Exclusion criteria
* Participants who were enrolled in a clinical trial or used a study drug within 3 months before administration of the study drug; * Participants with chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery within the past three years and still clinically relevant according to the investigator; * Participants with definite diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, metabolic system and other diseases that require medical intervention or are not suitable for clinical trial (such as psychiatric history); * With positive alcohol breath test; * Volunteers may not be able to complete the study for other reasons or have other reasons for not participating in the study as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) Of Jaktinib and its main metabolite ZG0244 | up to 48 hours | Maximum Plasma Concentration (Cmax) |
| Jaktinib and its main metabolite ZG0244 AUC(0-t) | up to 48 hours | Area under the concentration time curve from time 0 to time of the last quantifiable |
| Jaktinib and its main metabolite ZG0244 AUC(0-inf) | up to 48 hours | Area under the concentration time curve from time 0 to infinity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Jaktinib and its main metabolite ZG0244 Tmax | up to 48 hours | Maximum Plasma Concentration (Tmax) |
| Jaktinib and its main metabolite ZG0244 t1/2 | up to 48 hours | Half Life (t1/2) |
| Adverse events | Day 1 to Day 12 | — |
Countries
China
Outcome results
None listed