Actively Recruiting
Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on DA414
Led by Chendu DIAO Nine Hong Pharmaceutical Factory · Updated on 2024-07-29
82
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and Food Effects of DA414 Granules in Chinese healthy subjects with single and multiple doses.
CONDITIONS
Official Title
Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on DA414
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers fully informed of the study and signed consent
- Healthy adults aged 18 to 45 years
- Male weight at least 50 kg, female weight at least 45 kg; BMI between 19.0 and 26.0 kg/m2
- Willing to use effective contraception during the study and for 6 months after
- Able to communicate well and comply with study requirements
You will not qualify if you...
- History of allergies or allergic constitution including allergy to DA414 or its ingredients
- Acute illness within 2 weeks before screening
- History of serious or chronic diseases in major body systems within 1 year before screening
- Abnormal vital signs, physical exam, lab tests, chest X-ray, or abdominal ultrasound
- ECG showing QTc greater than 440 ms at screening
- Major surgery within 6 months before screening or planned during the study
- Use of any medication or nutraceuticals within 2 weeks before first dose
- Use of CYP3A4 or CYP2B6 inhibitors or inducers within 30 days before first dose
- Intake of substances affecting drug metabolism within 48 hours before dosing
- Live attenuated vaccination within 2 weeks before screening or planned during study
- Participation in another clinical trial within 3 months before screening
- Blood donation within 3 months before screening or significant blood loss within 6 months
- Average alcohol consumption over 2 units per week in past year or positive breath alcohol test
- Smoking more than 5 cigarettes per day in past 3 months or inability to stop tobacco use during study
- History or positive screen for substance abuse within past year
- Intolerance to venipuncture or difficulty swallowing
- Lactose intolerance
- Special dietary requirements incompatible with study diet
- Other conditions judged unsuitable by investigator
- For females: use of oral contraceptives within 30 days before screening
- Use of long-acting estrogen/progestin injections or implants within 6 months before screening
- Unprotected sex within 14 days before screening
- Positive pregnancy test or pregnant/lactating
AI-Screening
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Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China
Wuhan, Hubei.China, China, 430000
Actively Recruiting
Research Team
G
Guangxin Dong, Docter
CONTACT
X
Xiaolong Qin, PM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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