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Relative Bioavailability Study of HRG2010 in Healthy Subjects

NCT06976346 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-05-16

No results posted yet for this study

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

Interventions

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®.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-10
Primary Completion
2021-10-07
Completion
2021-10-07

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06976346 on ClinicalTrials.gov