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This is a single-center, open, randomized, single-dose, two-cycle, two-sequence, crossover pharmacokinetic study in healthy adult subjects.
The trial is planned to enroll 24 healthy subjects. Subjects will be randomized to one of two groups (Group A: T-R, Group B: R-T) according to the randomization table. The washout period (dosing interval) between doses will be at least 7 days. For example, for a washout period of 7 days, all subjects will receive the appropriate drug according to the randomized schedule on Day 1 of Cycle 1 and Day 8 of Cycle 2 of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test (T)-Reference (R) | Experimental | In this trial, 24 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 7 days. After fasting for at least 10 hours. |
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| Reference (R)-Test (T) | Experimental | In this trial, 24 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 7 days. After fasting for at least 10 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test (T) Aprepitant injection | Drug | Specification: Aprepitant injection 4.4ml∶32mg. Produced and supplied by Qilu Pharmaceutical (Hainan) Co. |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Evaluation of Peak Plasma Concentration (Cmax) | 72 hours |
| 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 | 72 hours |
| Area under the plasma concentration versus time curve (AUC0-∞) | Area Under the Plasma Drug Concentration-Time Curve from Time 0 to Infinite Time | 72 hours |
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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 trial; 2. Ability to complete research in accordance with the requirements of the pilot program; 3. Subjects (including male subjects) who have been using effective contraception for 14 days prior to the first dose and who are willing to voluntarily use effective contraception from the time of signing the information until 6 months after the last dose without pregnancy, sperm or egg donation program; 4. Male and female subjects aged 18-45 years (both 18 and 45 years); 5. Body mass index (BMI) within the range of 19.0~26.0kg/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 |
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| ID | Term |
|---|---|
| D000077608 | Aprepitant |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Reference (R) Aprepitant injection | Drug | Specification: Aprepitant injection 4.4ml∶32mg. Produced by Heron Therapeutics, Inc and supplied by Qilu Pharmaceutical (Hainan) Co. |
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