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The goal of this clinical study is to evaluate the bioavailability of two specifications of oral Deuteriumremidvir Hydrobromide for suspension in Chinese healthy adult participants. A total of 18 participants are planned to be enrolled and randomized into T-R or R-T sequence, 9 in each sequence with a single fasting administration in each period.
This is a single-center, randomized, open-label, two-period, crossover clinical study to evaluate the bioavailability of two specifications of oral deuteriumremidvir hydrobromide for suspension. With a washout period of 3 days, the dose is 200 mg in each sequence. The specification of the test formulation(T) is 200 mg and that for the reference formulation (R) is 100 mg. A total of 18 participants are planned to be enrolled and randomized into T-R or R-T sequence, 9 in each sequence with a single fasting administration in each period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test formulation(T) then reference formulation (R) of deuteriumremidvir hydrobromide for suspension | Experimental | On day 1 of the 1st period, participants will receive a single dose of the test formulation(T) (one bag of 200 mg deuteriumremidvir hydrobromide for suspension), and on day 1 of the 2nd period, participants will receive a single dose of the reference formulation(R) ( two bags of 100 mg deuteriumremidvir hydrobromide for suspension).The two periods are separated by a washout of 3 days. |
|
| reference formulation (R) then test formulation(T) deuteriumremidvir hydrobromide for suspension | Experimental | On day 1 of the 1st period, participants will receive a single dose of the reference formulation(R) ( two bags of 100 mg deuteriumremidvir hydrobromide for suspension), and on day 1 of the 2nd period, participants will receive a single dose of the test formulation(T) (one bag of 200 mg deuteriumremidvir hydrobromide for suspension).The two periods are separated by a washout of 3 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| test formulation(T) 200 mg deuteriumremidvir hydrobromide for suspension | Drug | Participants will receive a single dose of the test formulation(T) (one bag of 200 mg deuteriumremidvir hydrobromide for suspension). |
| 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] |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24h | area under the plasma concentration-time curve from 0 to 24 hours | 24 hours after administration |
| Tmax | time at which Cmax occurs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huan Zhou | The First Affiliated Hospital of Bengbu Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Xuzhou | Jiangsu | 233004 | China |
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| reference formulation(R) 100 mg deuteriumremidvir hydrobromide for suspension | Drug | Participants will receive a single dose of the reference formulation(R) ( two bags of 100 mg deuteriumremidvir hydrobromide for suspension). |
|
| 48 hours after administration |
| Tlag | time lag | 48 hours after administration |
| t1/2 | half life of elimination | 48 hours after administration |
| CLz/F | apparent clearance | 48 hours after administration |
| Vz/F | apparent volume of distribution during the terminal phase | 48 hours after administration |
| λz | first-order rate constant associated with the terminal (log-linear) portion of the curve | 48 hours after administration |
| MRT | mean residence time | 48 hours after administration |
| AE & SAE | Adverse event & serious adverse events | from day1 to day6 after administration |
| ID | Term |
|---|---|
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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