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This study is divided into three parts: bioavailability study (hereinafter referred to as "BA study"), food effect study (hereinafter referred to as "FE study") and pharmacokinetic characteristics study (hereinafter referred to as "PK characteristics study"). A total of 38 subjects are planned to be enrolled. The three parts of the study can be carried out simultaneously, and there is no order requirement. The subjects will be assigned to one of them according to the enrollment order. Dose selection is 100mg, 300mg and 25mg.
BA study plan included 18 subjects, in the form of dry suspension and tablets, with a dose of 100 mg. Subjects were randomly divided into two sequences, TR and RT, with 9 cases in each sequence. They were given once in fasted condition each period, and the dry suspension and tablets were designed in a double crossover way.
12 subjects were enrolled in the FE study plan, and the dose was 300mg in dry suspension. Subjects were randomly divided into two sequences, sequence 1 and sequence 2, with 6 cases in each sequence, and given once per period. Fasting and infant formula milk double crossover were tested in two periods according to the administration sequence.
PK study form is dry suspension, the doses are 25 mg, 100 mg, 300 mg, taken orally once in fasted condition. 8 subjects will be enrolled in the 25mg group. The 100 mg group used the data of 18 subjects with dry suspension in BA study, while the 300 mg group used the fasting condition data of 12 subjects with dry suspension in FE study. The 100 mg and 300 mg groups will not be enrolled separately.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BA Study | Experimental | 18 subjects were randomly divided into two sequences, TR and RT, with 9 subjects in each sequence, and were given in fasted condition once per period. In the first period of TR sequence, 100mg Deuremidevir Hydrobromide dry suspension was taken, and in the second period, 100 mg Deuremidevir Hydrobromide tablets were taken. In the first period of RT sequence, 100mg Deuremidevir Hydrobromide tablets were taken, and 100mg Deuremidevir Hydrobromide dry suspension was taken in the second period. |
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| FE Study | Experimental | 12 subjects were randomly divided into two sequences, sequence 1 and sequence 2. There were 6 subjects in each sequence, and one dose per period. Sequence 1: Take Deuremidevir Hydrobromide dry suspension in fasted condition in period 1, and take Deuremidevir Hydrobromide dry suspension after taking infant formula for 10 minutes in period 2; Sequence 2: Take Deuremidevir Hydrobromide dry suspension after taking infant formula for 10 minutes in period 1, and take Deuremidevir Hydrobromide dry suspension in fasted condition in period 2. |
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| PK Study | Experimental | Fasting; PK study form is dry suspension, the doses are 25 mg, 100 mg, 300 mg, taken orally once in fasted condition. 8 subjects in 25 mg group; The 100 mg group used the data of 18 subjects with dry suspension in BA study, while the 300 mg group used the fasting condition data of 12 subjects with dry suspension in FE study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deuremidevir Hydrobromide for Suspension 100mg | Drug | Take it with 240ml water in fasted condition. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax | maximum observed plasma concentration | 48 hours after administration |
| AUC0-t | area under the plasma concentration time curve from time zero to the last measurable concentration | 48 hours after administration |
| AUC0-∞ | area under the plasma concentration-time curve from time zero to infinity | 48 hours after administration |
| AUC0-24h | Area under the plasma concentration-time curve from 0 to 24 hours | 48 hours after administration |
| Tmax | time at which Cmax occurs | 48 hours after administration |
| Tlag | time lag | 48 hours after administration |
| t1/2z | half life of elimination | 48 hours after administration |
| CLz/F | apparent clearance | 48 hours after administration |
| Vz/F |
| Measure | Description | Time Frame |
|---|---|---|
| AE & SAE | Adverse event & serious adverse events | From Day1 to Day10 after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing Zhang | Hushan Hospital of the Fudan university | Principal Investigator |
| Xiaojie Wu | Hushan Hospital of the Fudan university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital affiliated to Fudan University | Shanghai | Shanghai Municipality | 201900 | China |
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| Deuremidevir Hydrobromide for Suspension 300mg | Drug | Take it with water in fasted condition or after taking infant formula. |
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| Deuremidevir Hydrobromide for Suspension 25mg | Drug | Take it with 240ml water on an empty stomach. |
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| Deuremidevir Hydrobromide tablets 100mg | Drug | Take it with 240ml water in fasted condition. |
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apparent volume of distribution during the terminal phase
| 48 hours after administration |
| ID | Term |
|---|---|
| D013535 | Suspensions |
| C000722705 | GS-621763 |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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