Comparative Study on Pharmacokinetics of Two Formulations of Jaktinib in Healthy Adults Under Fasting Conditions

Study Overview
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Brief Summary
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To evaluate the pharmacokinetic Characteristics of two formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers

Official Title
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A Single-dose, Randomized, Open-label, Repeated Cross-over Pharmacokinetic Comparison Study of Two Formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers Under Fasted Conditions

Conditions
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Myelofibrosis

Intervention / Treatment
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* Drug: Jaktinib Hydrochloride Tablets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>Subjects in the first sequence of the first cycle were administered with a test formulation (T) of 50 mg of Jaktinib on an empty stomach, while subjects in the second sequence were administered with a reference formulation (R) of 50 mg of Jaktinib on an empty stomach. The reference formulation (R) or test formulation (T) was administered alternately in the next periods. | Drug: Jaktinib Hydrochloride Tablets<br>* Orally, one tablet at a time<br>* Other names: Jaktinib;|
| Active Comparator: Reference Group<br>Subjects in the first sequence of the first cycle were administered with a test formulation (T) of 50 mg of Jaktinib on an empty stomach, while subjects in the second sequence were administered with a reference formulation (R) of 50 mg of Jaktinib on an empty stomach. The reference formulation (R) or test formulation (T) was administered alternately in the next periods. | Drug: Jaktinib Hydrochloride Tablets<br>* Orally, one tablet at a time<br>* Other names: Jaktinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) Of Jaktinib and its main metabolite ZG0244 | Maximum Plasma Concentration (Cmax) | up to 48 hours | 
| Jaktinib and its main metabolite ZG0244 AUC(0-t) | Area under the concentration time curve from time 0 to time of the last quantifiable | up to 48 hours | 
| Jaktinib and its main metabolite ZG0244 AUC(0-inf) | Area under the concentration time curve from time 0 to infinity | up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jaktinib and its main metabolite ZG0244 Tmax | Maximum Plasma Concentration (Tmax) | up to 48 hours | 
| Jaktinib and its main metabolite ZG0244 t1/2 | Half Life (t1/2) | up to 48 hours | 
| Adverse events |  | Day 1 to Day 12 |