Trials / Completed
CompletedNCT06614153
Pharmacokinetics,Pharmacodynamics,Efficacy and Safety of HRG2010 in Parkinson's Disease Patients With Motor Fluctuations
A Randomized, Open-label, Controlled, Single-dose, Multiple-dose Phase II Study to Evaluate the Pharmacokinetics,Pharmacodynamics,Efficacy and Safety of HRG2010 in Parkinson's Disease Patients With Motor Fluctuations
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The study is a multicenter, randomized, open-label, active-controlled, Phase II clinical study. The aim of this trial is to evaluated the pharmacokinetics, pharmacodynamics,efficacy and assessed the safety of HRG2010 compared with a sustained-release cabridopa-levodopa formulation in Parkinson's Disease Patients With Motor Fluctuations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HRG2010(I) | HRG2010(I) |
| DRUG | HRG2010(II) | HRG2010(II) |
| DRUG | Sustained-release Carbidopa/Levodopa | Sustained-release Carbidopa/Levodopa |
Timeline
- Start date
- 2023-05-16
- Primary completion
- 2024-01-31
- Completion
- 2024-03-04
- First posted
- 2024-09-26
- Last updated
- 2024-09-26
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06614153. Inclusion in this directory is not an endorsement.