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New treatment option for Cardiomyopathy
Official title A Bioequivalence Study of Two Formulations of HRS-1893 Tablets in Healthy Participants
ClinicalTrials.gov ID: NCT07479641
What this study is testing
What is Test formulation of HRS-1893 tablet?
Test formulation of HRS-1893 tablet is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cardiomyopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will investigate the bioequivalence between two formulations of HRS-1893 tablets. Safety and tolerability will also be assessed.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- people 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...
- No clinically significant abnormalities on the 12-lead ECG;
- The subject must understand the study procedures and methods, voluntarily agree to participate, and provide written informed consent.
You likely can't join if
- people 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 \<60 mmHg, as determined by the investigator to be...
- History of gastric or intestinal surgery that, in the investigator's judgment, may affect drug absorption;
- A positive result in any one of the following infectious disease screening tests during the screening period: hepatitis B surface antigen (HBsAg)...
- people who meet any of the following criteria will be excluded: a. Smoking: Average daily cigarette consumption of more than 5 cigarettes within the...
See the full eligibility criteria
- people 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...
- No clinically significant abnormalities on the 12-lead ECG;
- The subject must understand the study procedures and methods, voluntarily agree to participate, and provide written informed consent.
- people 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 \<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;
- A positive result in any one of the following infectious disease screening tests during the screening period: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody...
- people who meet any of the following criteria will be excluded: a. Smoking: Average daily cigarette consumption of more than 5 cigarettes within the 4 weeks prior to screening; b. Alcohol: Average daily alcohol intake...
- History of substance abuse;
- Use of any prescription drugs, over-the-counter medications, or Chinese herbal medicines within 1 month prior to dosing, or the use of any drug within 5 half-lives prior to screening (whichever is longer). Additionally...
- Any other circumstances that, in the investigator's judgment, make the subject unsuitable for participation in the trial. This includes physiological or psychological conditions that may increase the trial risk, affect...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.