Actively Recruiting
Relative Bioavailability of First vs Second-Generation Formulations of HRS9531 Tablets in Obese or Overweight Subjects
Led by Fujian Shengdi Pharmaceutical Co., Ltd. · Updated on 2025-11-17
168
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to compare the relative bioavailability, safety and tolerability of the first-generation and second-generation formulations of HRS9531 tablets, as well as to explore the safety, tolerability and pharmacokinetic characteristics of the second-generation formulation in terms of single-dose escalation.
CONDITIONS
Official Title
Relative Bioavailability of First vs Second-Generation Formulations of HRS9531 Tablets in Obese or Overweight Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand trial procedures and possible adverse events and willing to provide written informed consent
- Male subjects aged 18 to 55 years at consent
- Body weight at least 65 kg with BMI between 24.0 and 35.0 kg/m2
- Weight change within the last 3 months not exceeding 5 kilograms
- Overall health status judged suitable based on medical history, physical exam, vital signs, lab tests, and ECG
You will not qualify if you...
- Known or suspected allergy to any component of the investigational drug or related products
- History of multiple or severe allergies or severe immediate allergic reactions
- Chronic or severe diseases of respiratory, circulatory, digestive, urinary, blood, endocrine, immune, nervous, or mental systems judged unsuitable by investigators
- History of hypertension or clinically significant abnormal blood pressure at screening
- History of significant gastrointestinal diseases, symptoms, or surgeries affecting gastric emptying, or acute diarrhea within 7 days before dosing
- Participation in clinical trials of drugs or medical devices within 3 months or 5 half-lives before dosing
- Blood donation or blood loss over specified amounts within 1 to 3 months before dosing, or blood transfusion within 3 months
- Positive tests for hepatitis B surface antigen, HIV antibody, hepatitis C antibody, or treponema pallidum antibody
- History or positive screening for drug abuse
- Heavy drinking or smoking above specified limits, inability to quit during trial, or positive alcohol blood tests
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Actively Recruiting
Research Team
J
Jingjing Wang
CONTACT
T
Tong Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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