Actively Recruiting
A Study to Assess Effect of Dosing Intervals on Multiple-Dose Pharmacokinetics of WD-1603 Taken Before Meals in Healthy Participants
Led by Shanghai WD Pharmaceutical Co., Ltd. · Updated on 2026-04-08
12
Participants Needed
1
Research Sites
36 weeks
Total Duration
On this page
Sponsors
S
Shanghai WD Pharmaceutical Co., Ltd.
Lead Sponsor
S
Shanghai Xuhui Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
WD-1603 contains two different drugs called levodopa and carbidopa in one tablet. The goal of this clinical trial is to see if taking the study drug WD-1603 at different time intervals affects how the drug acts in healthy volunteers. We also want to learn about the safety of WD-1603. The main question we want to answer is: * How does the body process WD-1603 when it is taken by different time intervals? What will participants do? * Participants will take one tablet of WD-1603 twice a day on three separate days. * On each dosing day, the two doses will be spaced different hours apart. * Between each dosing day, there will be a rest period of up to 7 days.
CONDITIONS
Official Title
A Study to Assess Effect of Dosing Intervals on Multiple-Dose Pharmacokinetics of WD-1603 Taken Before Meals in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adult male or female aged 18 to 55 years
- Male body weight at least 50 kg; female body weight at least 45 kg
- Body mass index (BMI) between 18 and 27 kg/m2
- Normal or clinically insignificant results in medical history, physical exam, vital signs, lab tests, ECG, eye pressure, abdominal ultrasound, and chest X-ray
- No plans for conception or sperm/egg donation from signing consent until 3 months after last dose
- Willingness to use effective non-pharmacological contraception during the trial
- Ability to understand trial procedures and comply with requirements
- Voluntary agreement to participate and signed informed consent
You will not qualify if you...
- History of allergies or severe allergic reactions to levodopa, carbidopa, or related drugs
- Drug use within 3 months before screening, history of drug abuse, or positive drug screening
- History of glaucoma, cancer, diabetes, asthma, or significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, hematological, dermatological, endocrine, neuropsychiatric diseases
- Conditions affecting drug absorption or gastrointestinal diseases with symptoms
- History of orthostatic hypotension
- Relevant medical, surgical, or trauma history within 3 months before first dose or planned surgery during trial
- Use of prescription, over-the-counter, herbal, or dietary supplements within 4 weeks before first dose, especially monoamine oxidase inhibitors
- Participation in other clinical trials or use of investigational drugs within 3 months before first dose
- Blood donation, significant blood loss, transfusion, or blood product use within 3 months before first dose
- Difficulty with venous access or needle phobia
- Smoking more than 10 cigarettes daily within 3 months before screening
- Alcohol consumption over 21 standard units per week within 3 months before screening or positive alcohol breath test
- Abnormal kidney function (eGFR < 90 mL/min/1.73m2)
- Abnormal blood pressure or pulse rate outside specified limits
- History of prolonged QT interval or abnormal ECG findings
- Recent acute infections or gastrointestinal symptoms
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- Pregnant or breastfeeding females
- Poor compliance or other factors making participation unsuitable
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Xuhui Central Hospital
Shanghai, China
Actively Recruiting
Research Team
D
Danyong Zhang, Master
CONTACT
Y
Yan Jiao, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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