Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-center, randomized, open-label, four-period, crossover study. Primary Objective:
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
To assess safety following administration.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Period 1: HRG2010 dose 1 Period 2: HRG2010 dose 2 Period 3: Sinemet® Period 4: Madopar® |
|
| Sequence B | Experimental | Period 1: HRG2010 dose 2 Period 2: Madopar® Period 3: HRG2010 dose 1 Period 4: Sinemet® |
|
| Sequence C | Experimental | Period 1: Sinemet® Period 2: HRG2010 dose 1 Period 3: Madopar® Period 4: HRG2010 dose 2 |
|
| Sequence D | Experimental | Period 1: Madopar® Period 2: Sinemet® Period 3: HRG2010 dose 2 Period 4: HRG2010 dose 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRG2010 Capsule, Sinemet®, Madopar® | Drug | In each period under fasting conditions, subjects received oral administration of either HRG2010 Capsule dose 1, HRG2010 Capsule dose 2, Sinemet®, or Madopar®. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum plasma concentration. Blood samples will be collected. | From 0 hour predose up to 12 hours postdose | |
| AUC0-t: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected. | From 0 hour predose up to 12 hours postdose | |
| AUC0-∞: Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected. | From 0 hour predose up to 12 hours postdose | |
| Tmax: Observed time to reach Cmax. Blood samples will be collected. | From 0 hour predose up to 12 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent AEs (TEAEs) | From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 22) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Province Qianfoshan Hospital | Jinan | Shandong | 250000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
| C005177 | benserazide, levodopa drug combination |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |