Relative Bioavailability Study of HRG2010 in Healthy Subjects

NCT ID: NCT06976346

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-10
• Study Completion Date: 2021-10-07

Brief 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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sequence A

Period 1: HRG2010 dose 1 Period 2: HRG2010 dose 2 Period 3: Sinemet® Period 4: Madopar®

Group Type: EXPERIMENTAL

HRG2010 Capsule, Sinemet®, Madopar®

Intervention Type: DRUG

In each period under fasting conditions, subjects received oral administration of either HRG2010 Capsule dose 1, HRG2010 Capsule dose 2, Sinemet®, or Madopar®.

Sequence B

Period 1: HRG2010 dose 2 Period 2: Madopar® Period 3: HRG2010 dose 1 Period 4: Sinemet®

Group Type: EXPERIMENTAL

HRG2010 Capsule, Sinemet®, Madopar®

Intervention Type: DRUG

In each period under fasting conditions, subjects received oral administration of either HRG2010 Capsule dose 1, HRG2010 Capsule dose 2, Sinemet®, or Madopar®.

Sequence C

Period 1: Sinemet® Period 2: HRG2010 dose 1 Period 3: Madopar® Period 4: HRG2010 dose 2

Group Type: EXPERIMENTAL

HRG2010 Capsule, Sinemet®, Madopar®

Intervention Type: DRUG

In each period under fasting conditions, subjects received oral administration of either HRG2010 Capsule dose 1, HRG2010 Capsule dose 2, Sinemet®, or Madopar®.

Sequence D

Period 1: Madopar® Period 2: Sinemet® Period 3: HRG2010 dose 2 Period 4: HRG2010 dose 1

Group Type: EXPERIMENTAL

HRG2010 Capsule, Sinemet®, Madopar®

Intervention Type: DRUG

In each period under fasting conditions, subjects received oral administration of either HRG2010 Capsule dose 1, HRG2010 Capsule dose 2, Sinemet®, or Madopar®.

Interventions

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®.

Intervention Type: DRUG

Eligibility Criteria

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).

11. Clinical significance in vital signs, physical examination, 12 lead-ECG.

12. Positive results in any one of Hepatitis B virus surface antigen, hepatitis C virus antibody, HIV antibody or syphilis serum reagin test.

13. Female who are pregnant or breastfeeding.

14. Breath test for alcohol > 0.0 mg /mL.

15. Subjects who were positive in drug abuse or had a history of drug abuse.

16. Difficulty in venous blood collection or unable to tolerate venipuncture or a history of fainting due to needle or blood phobia.

17. Subjects with swallowing difficulties, or those with special dietary requirements that prevent them from adhering to a unified diet.

18. 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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shandong Province Qianfoshan Hospital

Jinan, Shandong, China

Countries

China

Other Identifiers

HRG2010-101

Identifier Type: -

Identifier Source: org_study_id