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Completed
NCT07479641
A Bioequivalence Study of Two Formulations of HRS-1893 Tablets in Healthy Participants
Conditions: Cardiomyopathy
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 58
Sponsor: Shandong Suncadia Medicine Co., Ltd.
Location: Beijing Hospital Beijing Beijing Municipality
Summary
This study will investigate the bioequivalence between two formulations of HRS-1893 tablets. Safety and tolerability will also be assessed.
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 \
Source: ClinicalTrials.gov (NCT07479641). StuddyBuddy aggregates publicly available trial information.