Parkinson's DiseasePhase 1NCT06976346
Relative Bioavailability Study of HRG2010 in Healthy Subjects
A Phase 1 study testing HRG2010 Capsule, Sinemet®, Madopar® in people with Parkinson's Disease, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, randomized, open-label, four-period, crossover study. Primary Objective： 1. To evaluate the pharmacokinetic characteristics of healthy subjects after a single oral dose of HRG2010 capsules at dose 1 and dose 2 under fasting conditions, and to compare these with the pharmacokinetic… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- HRG2010 Capsule, Sinemet®, Madopar®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2021to 7 Oct 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
- Healthy male or female between the ages of 18 and 45 years, inclusive.
- At least 50.0 kg for male subjects, 45.0 kg for female subjects, with a Body Mass Index (BMI) between 19.0-26.0 kg/m2, inclusive (BMI = weight/height2).
- Prior to screening, during the trial, and for 6 months after the trial, subjects (including male subjects) must not have plans to conceive and must voluntarily adopt effective contraceptive measures.
- Subjects who could understand the nature, significance, potential benefits, inconvenience, and potential risks of the study, understand the procedures and methods, be willing to complete the trial strictly following the protocol, and voluntarily sign the informed consent.
Who cannot join
- Subjects with history of drug or food allergies.
- Subjects with a history of diseases related to the circulatory, endocrine, nervous, digestive, respiratory, hematolymphatic, immune, mental, skin, bone, muscle, urogenital, mucosal, and metabolic systems, who are deemed by the investigator to be unsuitable for inclusion in this study.
- Subjects with a history of glaucoma.
- Use of any medication within 14 days prior to dosing.
- Subjects who have taken any clinical investigational products or participated in the clinical research of medical devices within 3 months before the trial, or plan to participate in other clinical trials during the study.
- Subjects who have donated blood or experienced blood loss greater than 300 mL, or have received a blood transfusion or used blood products within 3 months prior to screening, or plan to donate blood during the trial or within 1 month after the trial ends.
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- Subjects who had undergone major trauma surgery within 3 months before the screening, or planned a surgery during the study.
- Subjects who take more than 5 cigarettes per day on average within 3 months prior to the study or do not agree to prohibit smoking during the study.
- Drinking frequently within 6 months before the trial, meaning 14 units of alcohol per week（1 unit = 360 mL beer or 45 mL of 40% spirits, or 150 mL wine of 12% spirits), or disagree with the prohibition of alcohol during the study.
- Clinical significance in clinical laboratory tests (chemistry, hematology, urinalysis, coagulation function).
- Clinical significance in vital signs, physical examination, 12 lead-ECG.
- Positive results in any one of Hepatitis B virus surface antigen, hepatitis C virus antibody, HIV antibody or syphilis serum reagin test.
- Female who are pregnant or breastfeeding.
- Breath test for alcohol > 0.0 mg /mL.
- Subjects who were positive in drug abuse or had a history of drug abuse.
- Difficulty in venous blood collection or unable to tolerate venipuncture or a history of fainting due to needle or blood phobia.
- Subjects with swallowing difficulties, or those with special dietary requirements that prevent them from adhering to a unified diet.
- Unable to complete the study due to personal reasons or other factors considered by the investigator as unsuitable to participate in the study (such as inability to understand the study requirements, poor compliance, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics and Relative Bioavailability Study of HRG2010 Capsule After Single Dose Administration
This is a single-center, randomized, open-label, four-period, crossover study. Primary Objective：
- To evaluate the pharmacokinetic characteristics of healthy subjects after a single oral dose of HRG2010 capsules at dose 1 and dose 2 under fasting conditions, and to compare these with the pharmacokinetic characteristics of Carbidopa/Levodopa Extended-Release Tablets (Sinemet®) and Benserazide/Levodopa Tablets (Madopar®). Secondary Objective
- To assess safety following administration.
- Conditions
- Parkinson's Disease
- Being tested
- HRG2010 Capsule, Sinemet®, Madopar®
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRG2010 Capsule, Sinemet®, Madopar®Drug
In each period under fasting conditions, subjects received oral administration of either HRG2010 Capsule dose 1, HRG2010 Capsule dose 2, Sinemet®, or Madopar®.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Period 1: HRG2010 dose 1 Period 2: HRG2010 dose 2 Period 3: Sinemet® Period 4: Madopar® Receives: Drug: HRG2010 Capsule, Sinemet®, Madopar® |
| Sequence B | Experimental | Period 1: HRG2010 dose 2 Period 2: Madopar® Period 3: HRG2010 dose 1 Period 4: Sinemet® Receives: Drug: HRG2010 Capsule, Sinemet®, Madopar® |
| Sequence C | Experimental | Period 1: Sinemet® Period 2: HRG2010 dose 1 Period 3: Madopar® Period 4: HRG2010 dose 2 Receives: Drug: HRG2010 Capsule, Sinemet®, Madopar® |
| Sequence D | Experimental | Period 1: Madopar® Period 2: Sinemet® Period 3: HRG2010 dose 2 Period 4: HRG2010 dose 1 Receives: Drug: HRG2010 Capsule, Sinemet®, Madopar® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: Maximum plasma concentration. Blood samples will be collected.
Measured: From 0 hour predose up to 12 hours postdose
AUC0-t: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected.
Measured: From 0 hour predose up to 12 hours postdose
AUC0-∞: Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected.
Measured: From 0 hour predose up to 12 hours postdose
Tmax: Observed time to reach Cmax. Blood samples will be collected.
Measured: From 0 hour predose up to 12 hours postdose
Secondary outcomes (1)
Incidence of treatment emergent AEs (TEAEs)
Measured: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start10 Sep 2021
- Primary completion7 Oct 2021
- Study completion7 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976346
- Sponsor's protocol ID
- HRG2010-101
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Relative Bioavailability Study of HRG2010 Capsule After Single Dose Administration
- ClinicalTrials.gov ID
- NCT06976346
- Acronym / sponsor ID
- HRG2010-101
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 16 May 2025 (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.
This is a single-center, randomized, open-label, four-period, crossover study. Primary Objective：
- To evaluate the pharmacokinetic characteristics of healthy subjects after a single oral dose of HRG2010 capsules at dose 1 and dose 2 under fasting conditions, and to compare these with the pharmacokinetic characteristics of Carbidopa/Levodopa Extended-Release Tablets (Sinemet®) and Benserazide/Levodopa Tablets (Madopar®). Secondary Objective
- To assess safety following administration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: HRG2010 Capsule, Sinemet®, Madopar®Period 1: HRG2010 dose 1 Period 2: HRG2010 dose 2 Period 3: Sinemet® Period 4: Madopar® |
| Sequence B | Experimental | Drug: HRG2010 Capsule, Sinemet®, Madopar®Period 1: HRG2010 dose 2 Period 2: Madopar® Period 3: HRG2010 dose 1 Period 4: Sinemet® |
| Sequence C | Experimental | Drug: HRG2010 Capsule, Sinemet®, Madopar®Period 1: Sinemet® Period 2: HRG2010 dose 1 Period 3: Madopar® Period 4: HRG2010 dose 2 |
| Sequence D | Experimental | Drug: HRG2010 Capsule, Sinemet®, Madopar®Period 1: Madopar® Period 2: Sinemet® Period 3: HRG2010 dose 2 Period 4: HRG2010 dose 1 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female between the ages of 18 and 45 years, inclusive.
- At least 50.0 kg for male subjects, 45.0 kg for female subjects, with a Body Mass Index (BMI) between 19.0-26.0 kg/m2, inclusive (BMI = weight/height2).
- Prior to screening, during the trial, and for 6 months after the trial, subjects (including male subjects) must not have plans to conceive and must voluntarily adopt effective contraceptive measures.
- Subjects who could understand the nature, significance, potential benefits, inconvenience, and potential risks of the study, understand the procedures and methods, be willing to complete the trial strictly following the protocol, and voluntarily sign the informed consent.
Key exclusion criteria (18 listed)
- Subjects with history of drug or food allergies.
- Subjects with a history of diseases related to the circulatory, endocrine, nervous, digestive, respiratory, hematolymphatic, immune, mental, skin, bone, muscle, urogenital, mucosal, and metabolic systems, who are deemed by the investigator to be unsuitable for inclusion in this study.
- Subjects with a history of glaucoma.
- Use of any medication within 14 days prior to dosing.
- Subjects who have taken any clinical investigational products or participated in the clinical research of medical devices within 3 months before the trial, or plan to participate in other clinical trials during the study.
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 |
|---|---|---|
| HRG2010 Capsule, Sinemet®, Madopar®In each period under fasting conditions, subjects received oral administration of either HRG2010 Capsule dose 1, HRG2010 Capsule dose 2, Sinemet®, or Madopar®. | Drug | Sequence A, Sequence B, Sequence C, Sequence D |
Primary outcome
Cmax: Maximum plasma concentration. Blood samples will be collected.
Time frame: From 0 hour predose up to 12 hours postdose
AUC0-t: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected.
Time frame: From 0 hour predose up to 12 hours postdose
AUC0-∞: Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected.
Time frame: From 0 hour predose up to 12 hours postdose
Tmax: Observed time to reach Cmax. Blood samples will be collected.
Time frame: From 0 hour predose up to 12 hours postdose
1 secondary outcome
Incidence of treatment emergent AEs (TEAEs)
Time frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 22)
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 16 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 HRG2010 Capsule, Sinemet®, Madopar® in people with Parkinson's Disease, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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 4 inclusion and 18 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 16 May 2025. 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 China. 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. 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: Maximum plasma concentration. Blood samples will be collected. (time frame: From 0 hour predose up to 12 hours postdose). The study lists 4 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 16 May 2025.