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New treatment option for Healhty
Official title A Study to Assess Effect of Dosing Intervals on Multiple-Dose Pharmacokinetics of WD-1603 Taken Before Meals in Healthy Participants
ClinicalTrials.gov ID: NCT07442591
What this study is testing
What is Carbidopa and Levodopa Controlled-Release Tablets (25 mg/150 mg)?
Carbidopa and Levodopa Controlled-Release Tablets (25 mg/150 mg) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for healhty.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Participants (including their spouses or partners) have no plans for conception or for donating sperm/eggs from the time of signing the ICF (for...
- Fully understand the trial content, procedures, and potential adverse reactions, voluntarily agree to participate, and sign the ICF before any...
You likely can't join if
- Allergy-prone constitution, history of allergic diseases, or known severe allergic reaction or allergy history to levodopa/carbidopa or related...
- Drug use within 3 months prior to screening, history of drug abuse, or positive urine drug abuse screening (morphine, methamphetamine, ketamine...
- History of glaucoma, cancer, diabetes mellitus, bronchial asthma, or any clinically significant cardiovascular, respiratory, metabolic, renal...
- Dysphagia or any condition that may affect drug absorption (e.g., gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy), or...
- History of orthostatic hypotension.
- Any relevant medical history, surgical history, or trauma within 3 months prior to the first dose that may affect trial safety or drug...
See the full eligibility criteria
- 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...
- 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...
- Fully understand the trial content, procedures, and potential adverse reactions, voluntarily agree to participate, and sign the ICF before any trial-related procedures begin.
- Able to communicate well with the investigators and capable of understanding and complying with the requirements of this trial.
- 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...
- 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...
- History of orthostatic hypotension.
- Any relevant medical history, surgical history, or trauma within 3 months prior to the first dose that may affect trial safety or drug pharmacokinetics, or planned surgery during the trial period.
- Use of prescription drugs, over-the-counter medications, health products, Chinese herbal medicines, or dietary supplements within 4 weeks prior to the first dose, especially monoamine oxidase inhibitors (e.g...
- Participation in any clinical trial and receipt of investigational drugs within 3 months prior to the first dose.
- Blood donation (including component blood) or significant blood loss (≥400 mL), blood transfusion, or use of blood products within 3 months prior to the first dose.
- Difficulty with venous access, unsuitability or unwillingness to use intravenous catheters, or history of needle/blood phobia.
- Heavy smokers or average daily cigarette consumption of more than 10 cigarettes within 3 months prior to screening.
- Alcohol consumption exceeding 21 standard units per week within 3 months prior to screening (1 standard unit contains 14g of alcohol, e.g., 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine), positive alcohol...
- Estimated glomerular filtration rate (eGFR) \< 90 mL/min 1.73m² during the screening period.
- During screening: systolic blood pressure \ 100 beats/min or \< 50 beats/min.
- History of prolonged QT interval or other clinically significant cardiac diseases, or QTcF ≥ 450 ms on ECG during screening.
- Symptoms of acute infection (e.g., influenza) or acute gastroenteritis within 2 weeks prior to screening, or history of vomiting or diarrhea within 1 week prior to screening.
- Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody.
- Currently pregnant (including positive pregnancy test) or lactating female.
- Poor compliance as judged by the investigator, or other factors deemed unsuitable for participation in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.