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

ZGJAK037

To evaluate the pharmacokinetic Characteristics of two formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers

2023-11-29

2023-12-20

2023-12-20

Completed

Early phase I

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 52, 'type': 'ACTUAL'}}

2024-01-11