NCT06976346

Relative Bioavailability Study of HRG2010 in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	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®.

Timeline

• Start date: 2021-09-10
• Primary completion: 2021-10-07
• Completion: 2021-10-07
• First posted: 2025-05-16
• Last updated: 2025-05-16

Locations

1 site across 1 country: China