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This study is a non-randomized, open label trial aimed at evaluating the drug interaction between Buagafuran capsules and voriconazole tablets in Chinese adult healthy participants.The research period is 7 days in total.
This study is a single center, non-randomized, open label trial aimed at evaluating the drug interaction between Buagafuran capsules and voriconazole tablets in Chinese adult healthy participants.
The number of participants in this study is 18, and it is planned to enroll 4-6 participants for the trial first. After completing the day7 safety check, the remaining participants will enter the group.
Participants are required to take a single dose of 30 mg Buagafuran on the morning of day1 and day5. Voriconazole tablets (400 mg BID) orally on day3, and voriconazole tablets (200 mg BID) orally from day4 to day6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buagafuran+Voriconazole | Experimental | Participants took a single dose of 30 mg of Buagafuran capsules on day1 and day5; voriconazole tablets (400 mg, BID) on day3, and voriconazole tablets (200 mg, BID) from day4 to day6. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buagafuran | Drug | Buagafuran, oral administration 30mg, signal dose in the morning of day1 and day5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of Buagafuran( Cmax) | To evaluate the potential effect of multiple oral doses of Voriconazole on the single-dose PK of Buagafuran. Maximum observed concentration (Cmax). | From day1 to day7 |
| Pharmacokinetics of Buagafuran (AUC0-inf) | To evaluate the potential effect of multiple oral doses of Voriconazole on the single-dose PK of Buagafuran.Area under the concentration-time curve (AUC0-inf) from time zero to infinity. | From day1 to day7 |
| Pharmacokinetics of Buagafuran (AUC0-t) | To evaluate the potential effect of multiple oral doses of Voriconazole on the single-dose PK of Buagafuran.Area under the concentration-time curve (AUC0-t) time zero to last quantifiable concentration. | From day1 to day7 |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of adverse events | To assess the safety of combination of Buagafuran and voriconazole in healthy participants. | From day1 to day7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng You | Contact | 86+18911123155 | 18911123155@189.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hong Zhang | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Union Pharmaceutical Factory Ltd | Beijing | Beijing Municipality | 102600 | China |
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| ID | Term |
|---|---|
| C530322 | buagafuran |
| D065819 | Voriconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Voriconazole | Drug | Voriconazole tablets, oral administration 400 mg BID on day3, and Voriconazole tablets oral administration 200 mg BID from day4 to day6. |
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