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.
Sequential
Carbidopa and Levodopa Controlled-Release Tablets (25 mg/150 mg)
DrugAdministered twice daily for one day with a 5-hour interval between doses.
Carbidopa and Levodopa Controlled-Release Tablets (25 mg/150 mg)
DrugAdministered twice daily for one day with a 6-hour interval between doses.
Carbidopa and Levodopa Controlled-Release Tablets (25 mg/150 mg)
DrugAdministered twice daily for one day with a 7-hour interval between doses.
Maximal Plasma Concentration (Cmax) of Carbidopa and Levodopa
Maximal plasma concentration (Cmax) of carbidopa and levodopa after two doses of WD-1603 administered orally before meals at different dosing intervals in healthy participants.
Area under the Concentration versus Time Curve from 0 to Time t (AUC0-t) of Carbidopa and Levodopa
Area under the concentration versus time curve from 0 to time t (AUC0-t) of carbidopa and levodopa after two doses of WD-1603 administered orally before meals at different dosing intervals in healthy participants.
Area under the Concentration versus Time Curve from 0 Extrapolated to Infinity (AUC0-∞) of Carbidopa and Levodopa
Area under the concentration versus time curve from 0 extrapolated to infinity (AUC0-∞) of carbidopa and levodopa after two doses of WD-1603 administered orally before meals at different dosing intervals in healthy participants.
Time to Maximal Plasma Concentration (tmax) of Carbidopa and Levodopa
Time to maximal plasma concentration (tmax) of carbidopa and levodopa after two doses of WD-1603 administered orally before meals at different dosing intervals in healthy participants.
Number and Percentage of Participants for Each Type of Adverse Events (AEs)
All AEs will be coded using MedDRA version 28.1 or higher to provide the System Organ Class (SOC) and Primary Term (PT) for each event. AEs will be summarized by treatment period, including the number and percentage of participants for each event category and for treatment-related adverse events. Additionally, summarize treatment-emergent adverse events (TEAEs) by treatment period for deaths, serious adverse events (SAEs), events leading to discontinuation of study medication, and events leading to early termination of the study.
Number and Percentage of Participants with Abnormal Findings in Laboratory Tests, Physical Examinations, Vital Signs and 12-lead Electrocardiogram (12-lead ECG)
Summarize measurements recorded at each time point (screening, baseline, each visit, and study completion) along with changes from baseline at each visit and study completion. Use cross-tabulation to summarize baseline values for each indicator and the most clinically significant change determined post-treatment.
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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
