A Phase I Trial on the Relative Bioavailability and Food Effect of HRS-1893 Tablets in Healthy Subjects
Trial Parameters
Brief Summary
This Phase I clinical trial will investigate the relative bioavailability between two formulations of HRS-1893 tablets and the influence of food on the drug's pharmacokinetics in healthy adult participants. The safety and tolerability of HRS-1893 will also be monitored.
Eligibility Criteria
Inclusion Criteria: 1. Subjects aged 18 to 55 years (inclusive), regardless of gender. 2. Body mass index (BMI) between 19 and 28 kg/m² (inclusive), with body weight ≥50.0 kg and \<90.0 kg for men, and ≥45.0 kg and \<90.0 kg for women. 3. No abnormalities of clinical significance are found upon comprehensive physical examination and laboratory tests, or only minor abnormalities that are deemed by the investigator not to affect the subject's eligibility for enrollment. 4. No clinically significant abnormalities on the 12-lead ECG. 5. The subject must understand the study procedures and methods, voluntarily agree to participate, and provide written informed consent. Exclusion Criteria: 1. Subjects with suspected hypersensitivity to the investigational drug or any excipient. 2. The subject has a history of syncope. 3. Exclusion due to blood pressure: Systolic Blood Pressure (SBP) \>140 mmHg or \<90 mmHg; OR Diastolic Blood Pressure (DBP) \>90 mmHg or \<60 mmHg, as determined by the invest