Status:
COMPLETED
Comparative Study on Pharmacokinetics of Two Formulations of Jaktinib in Healthy Adults Under Fasting Conditions
Lead Sponsor:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Conditions:
Myelofibrosis
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
To evaluate the pharmacokinetic Characteristics of two formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06132243
Start Date
November 29 2023
End Date
December 20 2023
Last Update
January 11 2024
Active Locations (1)
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1
The Third Hospital of Changsha
Changsha, Hunan, China, 410011