Parkinson DiseasePhase 1NCT05128175
Comparative Bioavailability Study of Carbidopa/Levodopa Extended-Release Tablets Under Fasting and Fed Conditions
A Phase 1 study testing WD-1603 Carbidopa-Levodopa Extended-Release Tablets in people with Parkinson Disease, run by Shanghai WD Pharmaceutical Co., Ltd. at 1 site in India.
Trial summary
It is an open-label, balanced, randomized, five-treatment, five-period, five-sequence, multiple oral dose, crossover comparative bioavailability study of different strengths of carbidopa/levodopa extended-release tablets with carbidopa and levodopa tablets in normal, healthy adult human subjects under fasting and fed… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- WD-1603 Carbidopa-Levodopa Extended-Release Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteIndia
- Study dates
- 29 Oct 2021to 9 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal, healthy adult human volunteers between 18 to 45 years of age (both inclusive).
- Having a Body Mass Index (BMI) between 18.5 to 29.9 (both inclusive), calculated as weight in kg/ height in m2, a minimum body weight of 50.0 kg.
- Not having any significant disease or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12- lead ECG, and X-ray chest (P/A view) recordings.
- In the case of female subjects:
- Surgically sterilized at least 6 months prior to study participation or If of childbearing potential is willing to use a suitable and effective double barrier contraceptive method or intra-uterine device during the study and for at least 28 days after the last study drug administration.
- And b. Serum Pregnancy test must be negative.
Who cannot join
- Known hypersensitivity or idiosyncratic reaction to Carbidopa or Levodopa or any of the excipients or any related drug.
- History or presence of any disease or condition which might compromise the hemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, or any other body system.
- Ingestion of a medicine (prescribed \& over the counter (OTC) medication including herbal remedies and MAO inhibitors) at any time within 30 days before first dosing in Period I. In any such case, subject selection will be at the discretion of the Principal Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Balanced, Randomized, Five-treatment, Five-period, Five-sequence, Multiple Oral Dose, Crossover Comparative Bioavailability Study of Different Strengths of Carbidopa/Levodopa Extended-release Tablets With Carbidopa and Levodopa Tablets in Normal, Healthy Adult Human Subjects Under Fasting and Fed Conditions
It is an open-label, balanced, randomized, five-treatment, five-period, five-sequence, multiple oral dose, crossover comparative bioavailability study of different strengths of carbidopa/levodopa extended-release tablets with carbidopa and levodopa tablets in normal, healthy adult human subjects under fasting and fed conditions. The primary objective of the study is to compare the pharmacokinetic profiles between WD-1603 extended-release formulations and carbidopa and levodopa tablets 25mg/100mg following three times a day after oral administration in fasting and fed conditions in healthy subjects and to compare relative bioavailability between treatments.
Read the detailed description
Study WD-1603-1005 is to compare the fluctuation index between WD-1603 extended-release formulations and Carbidopa and Levodopa Tablets following three times a day oral administration and the food effect on the initial absorption of levodopa in the morning in healthy subjects. At least 15 subjects will be enrolled at the beginning of the study and the order of receiving the Treatment A, B, C, D \& E for each subject during all the periods of the the study will be determined according to a randomization schedule.
- Conditions
- Parkinson Disease
- Being tested
- WD-1603 Carbidopa-Levodopa Extended-Release Tablets
- Keywords
- WD-1603, Carbidopa-Levodopa Extended-Release Tablets
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WD-1603 Carbidopa-Levodopa Extended-Release TabletsDrug
Also called WD-1603
For fasting conditions in the morning, a single oral dose will be administered to each subject under fasting conditions before 5 minutes of serving a standardized vegetarian breakfast as per the randomization schedule; for fasting conditions in the afternoon and evening, a single oral dose will be administered to each subject under fasting condition before 5 minutes of serving standardized vegetarian lunch and dinner as per randomization schedule. For fed condition, single oral dose will be administered to each subject after 30 minutes of serving standardized vegetarian breakfast, lunch and dinner as per randomization schedule. Dosing interval between two subsequent dosing should be 5 hours in each period. There will be one tablet for A, B, C, D and E.
| Study group | Role | What they receive |
|---|---|---|
| 25 mg /100 mg treatment A group | Experimental | Treatment A: carbidopa/levodopa (25 mg /100 mg) Receives: Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets |
| 25 mg /150 mg treatment B group | Experimental | Treatment B: carbidopa/levodopa (25 mg/150mg) Receives: Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets |
| 25 mg /150 mg treatment C group | Experimental | Treatment C: carbidopa/levodopa (25 mg /150 mg) Receives: Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets |
| 25 mg /150 mg treatment D group | Experimental | Treatment D: carbidopa/levodopa (25 mg /150 mg) Receives: Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets |
| 25 mg /100 mg placebo group | Placebo comparator | Treatment E(Reference): Carbidopa and Levodopa tablets (a generic version of Sinemet® IR) 25 mg/100 mg Receives: Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of the pharmacokinetics of WD-1603 extended-release formulations and carbidopa and levodopa tablets 25mg/100mg from the morning of day 1 to the morning of day 2.
To evaluate Cmax (Maximum Plasma Concentration) of the pharmacokinetics of WD-1603 extended-release formulations and carbidopa and levodopa tablets 25mg/100mg following three times a day after oral administration in fasting and fed conditions in healthy subjects.
Measured: 24 hours-from morning of Day 1 to morning of Day 2
The duration (hours) for the levodopa concentrations ≥ 50% of Cmax between WD-1603 extended-release formulations and carbidopa and levodopa tablets following three times a day orally administration in healthy subjects.
To compare the duration (hours) for the levodopa concentrations ≥ 50% of Cmax, where maximum measured plasma concentration after 1st dose or 2nd or 3rd dose for each dose interval.
Measured: 24 hours-from morning of Day 1 to morning of Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start29 Oct 2021
- Primary completion9 Dec 2021
- Study completion9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai WD Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akash Patel, M.D., Principal investigator, Lambda Therapeutic Research Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128175
- Sponsor's protocol ID
- WD-1603-1005
- Status last verified
- Aug 2026
- First submitted
- 27 Oct 2021
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Balanced, Randomized, Five-treatment, Five-period, Five-sequence, Multiple Oral Dose, Crossover Comparative Bioavailability Study of Different Strengths of Carbidopa/Levodopa Extended-release Tablets With Carbidopa and Levodopa Tablets in Normal, Healthy Adult Human Subjects Under Fasting and Fed Conditions
- ClinicalTrials.gov ID
- NCT05128175
- Acronym / sponsor ID
- WD-1603-1005
- Conditions
- Parkinson Disease
- Keywords
- WD-1603, Carbidopa-Levodopa Extended-Release Tablets
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Shanghai WD Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is an open-label, balanced, randomized, five-treatment, five-period, five-sequence, multiple oral dose, crossover comparative bioavailability study of different strengths of carbidopa/levodopa extended-release tablets with carbidopa and levodopa tablets in normal, healthy adult human subjects under fasting and fed conditions. The primary objective of the study is to compare the pharmacokinetic profiles between WD-1603 extended-release formulations and carbidopa and levodopa tablets 25mg/100mg following three times a day after oral administration in fasting and fed conditions in healthy subjects and to compare relative bioavailability between treatments.
Detailed description
Study WD-1603-1005 is to compare the fluctuation index between WD-1603 extended-release formulations and Carbidopa and Levodopa Tablets following three times a day oral administration and the food effect on the initial absorption of levodopa in the morning in healthy subjects. At least 15 subjects will be enrolled at the beginning of the study and the order of receiving the Treatment A, B, C, D \& E for each subject during all the periods of the the study will be determined according to a randomization schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 25 mg /100 mg treatment A group | Experimental | Drug: WD-1603 Carbidopa-Levodopa Extended-Release TabletsTreatment A: carbidopa/levodopa (25 mg /100 mg) |
| 25 mg /150 mg treatment B group | Experimental | Drug: WD-1603 Carbidopa-Levodopa Extended-Release TabletsTreatment B: carbidopa/levodopa (25 mg/150mg) |
| 25 mg /150 mg treatment C group | Experimental | Drug: WD-1603 Carbidopa-Levodopa Extended-Release TabletsTreatment C: carbidopa/levodopa (25 mg /150 mg) |
| 25 mg /150 mg treatment D group | Experimental | Drug: WD-1603 Carbidopa-Levodopa Extended-Release TabletsTreatment D: carbidopa/levodopa (25 mg /150 mg) |
| 25 mg /100 mg placebo group | Placebo comparator | Drug: WD-1603 Carbidopa-Levodopa Extended-Release TabletsTreatment E(Reference): Carbidopa and Levodopa tablets (a generic version of Sinemet® IR) 25 mg/100 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Normal, healthy adult human volunteers between 18 to 45 years of age (both inclusive).
- Having a Body Mass Index (BMI) between 18.5 to 29.9 (both inclusive), calculated as weight in kg/ height in m2, a minimum body weight of 50.0 kg.
- Not having any significant disease or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12- lead ECG, and X-ray chest (P/A view) recordings.
- In the case of female subjects:
- Surgically sterilized at least 6 months prior to study participation or If of childbearing potential is willing to use a suitable and effective double barrier contraceptive method or intra-uterine device during the study and for at least 28 days after the last study drug administration.
Key exclusion criteria (3 listed)
- Known hypersensitivity or idiosyncratic reaction to Carbidopa or Levodopa or any of the excipients or any related drug.
- History or presence of any disease or condition which might compromise the hemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, or any other body system.
- Ingestion of a medicine (prescribed \& over the counter (OTC) medication including herbal remedies and MAO inhibitors) at any time within 30 days before first dosing in Period I. In any such case, subject selection will be at the discretion of the Principal Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WD-1603 Carbidopa-Levodopa Extended-Release TabletsAlso: WD-1603For fasting conditions in the morning, a single oral dose will be administered to each subject under fasting conditions before 5 minutes of serving a standardized vegetarian breakfast as per the randomization schedule; for fasting conditions in the afternoon and evening, a single oral dose will be administered to each subject under fasting condition before 5 minutes of serving standardized vegetarian lunch and dinner as per randomization schedule. For fed condition, single oral dose will be administered to each subject after 30 minutes of serving standardized vegetarian breakfast, lunch and dinner as per randomization schedule. Dosing interval between two subsequent dosing should be 5 hours in each period. There will be one tablet for A, B, C, D and E. | Drug | 25 mg /100 mg placebo group, 25 mg /100 mg treatment A group, 25 mg /150 mg treatment B group, 25 mg /150 mg treatment C group, 25 mg /150 mg treatment D group |
Primary outcome
Cmax of the pharmacokinetics of WD-1603 extended-release formulations and carbidopa and levodopa tablets 25mg/100mg from the morning of day 1 to the morning of day 2.
Time frame: 24 hours-from morning of Day 1 to morning of Day 2
To evaluate Cmax (Maximum Plasma Concentration) of the pharmacokinetics of WD-1603 extended-release formulations and carbidopa and levodopa tablets 25mg/100mg following three times a day after oral administration in fasting and fed conditions in healthy subjects.
The duration (hours) for the levodopa concentrations ≥ 50% of Cmax between WD-1603 extended-release formulations and carbidopa and levodopa tablets following three times a day orally administration in healthy subjects.
Time frame: 24 hours-from morning of Day 1 to morning of Day 2
To compare the duration (hours) for the levodopa concentrations ≥ 50% of Cmax, where maximum measured plasma concentration after 1st dose or 2nd or 3rd dose for each dose interval.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akash Patel, M.D. principal investigator
Lambda Therapeutic Research Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WD-1603 Carbidopa-Levodopa Extended-Release Tablets in people with Parkinson Disease, run by Shanghai WD Pharmaceutical Co., Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of the pharmacokinetics of WD-1603 extended-release formulations and carbidopa and levodopa tablets 25mg/100mg from the morning of day 1 to the morning of day 2. (time frame: 24 hours-from morning of Day 1 to morning of Day 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.