Comparative Study on Pharmacokinetics of Two Formulations of Jaktinib in Healthy Adults Under Fasting Conditions
- Registration Number
- NCT06132243
- Lead Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Brief Summary
To evaluate the pharmacokinetic Characteristics of two formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Test Group Jaktinib Hydrochloride Tablets 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. Reference Group Jaktinib Hydrochloride Tablets 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.
- Primary Outcome Measures
Name Time Method 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-inf) up to 48 hours Area under the concentration time curve from time 0 to infinity
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
- Secondary Outcome Measures
Name Time Method Adverse events Day 1 to Day 12 Jaktinib and its main metabolite ZG0244 t1/2 up to 48 hours Half Life (t1/2)
Jaktinib and its main metabolite ZG0244 Tmax up to 48 hours Maximum Plasma Concentration (Tmax)
Trial Locations
- Locations (1)
The Third Hospital of Changsha
🇨🇳Changsha, Hunan, China