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Relative Bioavailability Study of HRG2010 in Healthy Subjects

Pharmacokinetics and Relative Bioavailability Study of HRG2010 Capsule After Single Dose Administration

NCT06976346•Jiangsu HengRui Medicine Co., Ltd.

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 characteristics of Carbidopa/Levodopa Extended-Release Tablets (Sinemet®) and Benserazide/Levodopa Tablets (Madopar®). Secondary Objective 2. To assess safety following administration.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy male or female between the ages of 18 and 45 years, inclusive.
•2. 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).
•3. 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.
•4. 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.

Exclusion Criteria

•1. Subjects with history of drug or food allergies.
•2. 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.
•3. Subjects with a history of glaucoma.
•4. Use of any medication within 14 days prior to dosing.
•5. 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.
•6. 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.
•7. Subjects who had undergone major trauma surgery within 3 months before the screening, or planned a surgery during the study.
•8. 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.
•9. 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.
•10. Clinical significance in clinical laboratory tests (chemistry, hematology, urinalysis, coagulation function).
+8 more criteria

Locations (1)

Shandong Province Qianfoshan Hospital

Jinan, Shandong, China

Key Dates

Start Date

September 10, 2021

Primary Completion Date

October 7, 2021

Completion Date

October 7, 2021

Last Updated

May 16, 2025

Enrollment

ACTUAL participants

Conditions

Parkinson's Disease

Interventions

HRG2010 Capsule, Sinemet®, Madopar®

DRUG

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

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Deep Brain Stimulation Therapy in Movement Disorders

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Parkinson's Disease

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Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Relative Bioavailability Study of HRG2010 in Healthy Subjects

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Deep Brain Stimulation Therapy in Movement Disorders

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations