A Bioequivalence Study of Two Formulations of HRS-1893 Tablets in Healthy Participants
ConditionCardiomyopathy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShandong Suncadia Medicine Co., Ltd.
About this trial
This study will investigate the bioequivalence between two formulations of HRS-1893 tablets. Safety and tolerability will also be assessed.
Eligibility criteria
Qualifiers
Subjects aged 18 to 55 years (inclusive), regardless of gender;
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;
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;
No clinically significant abnormalities on the 12-lead ECG;
Disqualifiers
Subjects with suspected hypersensitivity to the investigational drug or any excipient;
The subject has a history of syncope;
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 investigator to be clinically significant;
History of gastric or intestinal surgery that, in the investigator's judgment, may affect drug absorption;
Trial design
Treatments tested in this trial
- Test formulation of HRS-1893 tablet
- Reference formulation of HRS-1893 tablet
Treatment groups
58 Participants
are divided into 2 treatment groupsLocations
1Beijing Hospital100730, BeijingBeijing Municipality, China
Sponsors and collaborators
Shandong Suncadia Medicine Co., Ltd.
Lead sponsor
Source ClinicalTrials.gov