drugset / Trial / NCT06976346
Relative Bioavailability Study of HRG2010 in Healthy Subjects
RandomizedCrossoverOpen-labelDiagnostic
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.
Timeline
- Start
- 2021-09-10
- Primary completion
- 2021-10-07
- Completion
- 2021-10-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Benserazide/Levodopa | Unknown | — | Oral |
| Subject | Carbidopa/Levodopa | Unknown | — | Oral |
| Subject | HRG2010 | Unknown | — | Oral |