Actively Recruiting
A Bioequivalence Study of Two Formulations of HRS-1893 Tablets in Healthy Participants
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-04-17
36
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether two different formulations of HRS-1893 tablets are bioequivalent in healthy adults aged 18 to 55 years. This Phase 1 study aims to compare how the body absorbs and processes these two tablet versions, while also assessing their safety and tolerability. The study is sponsored by Shandong Suncadia Medicine Co., Ltd. and focuses on the condition of cardiomyopathy. Participants will be randomly assigned to receive either the test formulation or the reference formulation of the HRS-1893 tablet taken orally. The study includes precise monitoring of drug levels in the blood from Day 1 to Day 17, measuring peak concentration and overall exposure. Safety assessments such as ECG, echocardiogram, vital signs, and adverse event monitoring occur from Day 1 to Day 21, with no masking or blinding involved. During the study, participants will undergo blood tests to measure drug concentration over time, along with heart function tests and vital sign checks. Researchers will track any adverse effects and evaluate how well participants tolerate the treatments. The study involves multiple visits over several weeks, providing detailed information on how the tablets behave in the body and their safety profile.
CONDITIONS
Brief Title
A Bioequivalence Study of Two Formulations of HRS-1893 Tablets in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged 18 to 55 years inclusive, any gender
- Body mass index between 19 and 28 kg/m²
- Body weight at least 50 kg and less than 90 kg for men
- Body weight at least 45 kg and less than 90 kg for women
- No significant abnormalities on physical exam, lab tests, or ECG
- Ability to understand study procedures and provide written informed consent
You will not qualify if you...
- Known allergy or hypersensitivity to the study drug or its ingredients
- History of fainting (syncope)
- Blood pressure outside the range of 90-140 mmHg systolic or 60-90 mmHg diastolic
- History of stomach or intestinal surgery affecting drug absorption
- Positive test for hepatitis B, hepatitis C, syphilis, or HIV
- Smoking more than 5 cigarettes daily within 4 weeks before screening
- Drinking more than 15 grams of alcohol daily within 1 week before screening
- Inability or unwillingness to abstain from smoking, alcohol, or caffeine during the study
- Special dietary needs or history of substance abuse
- Use of prescription, over-the-counter, or herbal medications within 1 month before dosing
- Any other condition judged by the investigator to interfere with study participation or safety
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 17 days
Participants receive two different formulations of HRS-1893 tablets in a randomized crossover design to compare their effects.
Multiple visits during the 17-day treatment period
Duration - Up to 4 days
Participants are monitored for safety including adverse events, ECG, echocardiogram, and vital signs after treatment ends.
Visits up to Day 21 ± 2 days
Trial Site Locations
Total: 1 location
1
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
W
Wenzheng Xiong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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