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.
Healthy adult male or female participants aged 18 to 55 years (inclusive) at the time of signing the informed consent form (ICF).
Body weight: male ≥ 50 kg, female ≥ 45 kg; body mass index (BMI) between 18 and 27 kg/m² (inclusive) (BMI = weight [kg] / height² [m²]).
Medical history inquiry, physical examination, vital signs, laboratory tests (complete blood count, urinalysis, blood biochemistry, serological virology tests, coagulation function), 12-lead ECG, intraocular pressure measurement, abdominal ultrasound, and chest X-ray during the screening period are all within normal ranges or clinically insignificant if outside normal ranges.
Participants (including their spouses or partners) have no plans for conception or for donating sperm/eggs from the time of signing the ICF (for females)/first dosing (for males) until 3 months after the last dose, and voluntarily agree to use effective non-pharmacological contraception during the trial period.
Allergy-prone constitution, history of allergic diseases, or known severe allergic reaction or allergy history to levodopa/carbidopa or related medications.
Drug use within 3 months prior to screening, history of drug abuse, or positive urine drug abuse screening (morphine, methamphetamine, ketamine, methylenedioxymethamphetamine, tetrahydrocannabinol acid, cocaine).
History of glaucoma, cancer, diabetes mellitus, bronchial asthma, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, hematological, dermatological, endocrine, neuropsychiatric diseases, or other significant conditions.
Dysphagia or any condition that may affect drug absorption (e.g., gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy), or gastrointestinal diseases causing clinically significant symptoms such as nausea, vomiting, diarrhea, or malabsorption syndrome.
Shanghai WD Pharmaceutical Co., Ltd.
Lead sponsor
Shanghai Xuhui Central Hospital
Collaborator
BalGenSource Medical Technology Co. Ltd.
Collaborator
Shanghai Xihua Scientific Co., Ltd.
Collaborator
Shanghai BioGuider Medical Technology Co., Ltd.
Collaborator