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This study is designed to estimate the drug interaction between RIF and ABT. This will be a single-center, open-label, parallel study in healthy adult subjects.
The purpose of this study is to describe and compare RIF and ABT pharmacokinetics following administration of 320mg ABT and 600mg RIF.12 subjects will receive 320mg ABT on Days 1、2、3、8 (Treatment 1). And 12 subjects will receive 600mg RIF daily for 16 days from Day 1 to 16, and receive 320mg ABT on Days 7、8、9 and 14 (Treatment 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: ABT | Experimental | Intravenous infusion of 320 mg ABT on Day 1, 2, 3, and 8. |
|
| Group 2: ABT+RIF | Experimental | 600mg Rifampicin once daily from Day 1 to 16. Intravenous infusion of 320 mg ABT on Day 7, 8, 9 and 14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT | Drug | 320 mg, Intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of ABT following ABT 320mg administration with and without RIF 600mg qd | Pharmacokinetic(PK) parameters | Up to 17 days |
| Peak Plasma Concentration (Cmax) of RIF 600mg qd administration with and without ABT 320mg | PK parameters | Up to 17 days |
| Area under the plasma concentration versus time curve (AUC) of ABT following ABT 320mg administration with and without RIF 600mg qd | PK parameters | Up to 17 days |
| Area under the plasma concentration versus time curve (AUC) of RIF 600mg qd administration with and without ABT 320mg | PK parameters | Up to 17 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with abnormal findings for laboratory parameters | Number of subjects with Grade 3/4 laboratory parameters | Up to 17 days |
| Number of subjects with adverse events. | An adverse event is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongzhou Lu, Ph.D | Shanghai Public Health Clinical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Public Health Clinical Center | Shanghai | Shanghai Municipality | 201508 | China |
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| ID | Term |
|---|---|
| C573334 | albuvirtide |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| RIF | Drug | 600mg q.d. |
|
|
| Up to 17 days |
| Number of subjects with severity of adverse events | The Division of AIDS table for grading the severity of adult and pediatric adverse events will be used to assess severity. | Up to 17 days |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |