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In this trial, 32 healthy subjects are planned to be enrolled in fasting and 36 healthy subjects are planned to be enrolled in postprandial, and the fasting and 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 5 days. Taking the washout period of 5 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 6 of the second cycle trial, day 11 of the third cycle trial, and day 16 of the fourth cycle trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting state | Experimental | In this trial, 32 healthy subjects are planned to be enrolled in fasting. 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 5 days. After fasting for at least 10 hours, subjects were given either the test formulation (T) Entacapone, Levodopa and Carbidopa Tablets (II) or the reference formulation (R) Entacapone,Levodopa and Carbidopa Tablets (II) in 240 milliliter (mL) of warm water. 1 tablet 100mg/25mg/200mg orally per cycle. |
|
| Fed state | Experimental | In this trial, 36 healthy subjects are planned to be enrolled in postprandial. 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 5 days. After fasting for at least 10 hours, subjects were given a high-fat, high-calorie meal 30 minutes prior to dosing, which was completed within 30 minutes. 30 minutes after the start of the meal, the test formulation (T) Entacapone,Levodopa and Carbidopa Tablets (II) or the reference formulation (R)Entacapone,Levodopa and Carbidopa Tablets (II) were administered in 240 milliliter of warm water. Take 1 tablet 100mg/25mg/200mg orally per cycle. |
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| 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:
1. Voluntarily sign an informed consent form before the trial and fully understand the content, process and possible adverse effects of the trialï¼› 2. Ability to complete research in accordance with the requirements of the pilot programï¼› 3. The subject is willing to be free of pregnancy, sperm or egg donation and to voluntarily use effective contraception from the time of signing (female subject has used effective contraception for 14 days prior to the first dose of the drug) to 6 months after the last dose of the drugï¼› 4. Healthy male and female subjects aged 18 years or older (including 18 years of age)ï¼› 5. Male subjects weighed no less than 50.0 kg and female subjects weighed no less than 45.0 kg, with a body mass index in the range of 19.0 to 28.0 kg/m2 (including threshold values).
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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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| ID | Term |
|---|---|
| C071192 | entacapone |
| D007980 | Levodopa |
| D002230 | Carbidopa |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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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. |
|
| 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 |