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In this trial, 36 healthy subjects are planned to be enrolled in postprandial, and the postprandial trials will be randomized separately. According to the randomization table, subjects will be randomly assigned to one of the two groups (Group A: TRTR, Group B: RTRT). The washout period (dosing interval) between doses will be at least 2 days. Taking the washout period of 2 days as an example, all subjects will take the corresponding medication according to the randomization table on day 1 of the first cycle trial, day 3 of the second cycle trial, day 5 of the third cycle trial, and day 7 of the fourth cycle trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test (T)-Reference (R) | Experimental | In this trial, 36 healthy subjects are planned to be enrolled in fasting. According to the randomization table, subjects will be randomly assigned to the Group A: Test (T)-Reference (R), The washout period (dosing interval) between doses will be at least 2 days. After fasting for at least 10 hours. |
|
| Reference (R)-Test (T) | Experimental | In this trial, 36 healthy subjects are planned to be enrolled in fasting. According to the randomization table, subjects will be randomly assigned to the Group B: Reference (R)-Test (T), The washout period (dosing interval) between doses will be at least 2 days. After fasting for at least 10 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test (T) Entacapone,Levodopa and Carbidopa Tablets (II) | Drug | Specification:Levodopa 100mg, Carbidopa 25mg, Entacapone 200mg(Abbreviation: 100mg/25mg/200mg). Produced and supplied by Qilu Pharmaceutical Co. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Evaluation of Peak Plasma Concentration (Cmax) | 10hours |
| Area under the plasma concentration versus time curve (AUC0-t) | Area under the drug concentration-time curve from time 0 to the last accurately measurable concentration at sample collection time t | 10hours |
| Area under the plasma concentration versus time curve (AUC0-∞) | Area Under the Plasma Drug Concentration-Time Curve from Time 0 to Infinite Time | 10hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Cao | Contact | 18661809090 | caoyu1767@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yu Cao | The Affiliated Hospital of Qingdao University Phase I Clinical Research Center | Principal Investigator |
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| Reference (R) Entacapone,Levodopa and Carbidopa Tablets (II) | Drug | Specification:Levodopa 100mg, Carbidopa 25mg, Entacapone 200mg(Abbreviation: 100mg/25mg/200mg). Supplied by Qilu Pharmaceutical Co. |
|
| ID | Term |
|---|---|
| C071192 | entacapone |
| D007980 | Levodopa |
| D002230 | Carbidopa |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
| D008750 | Methyldopa |
| D006834 | Hydrazines |
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