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The primary objective of this study is to characterise the pharmacokinetics and dose proportionality of daptomycin after single and multiple (once daily) 4mg/kg and 6 mg/kg doses of daptomycin in healthy Chinese volunteers.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daptomycin | Drug | 4mg/kg and 6 mg/kg dissolved in 0.9% sodium chloride for injection, administered intravenously over 30 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic data will be obtained from the analysis of blood and urine samples that will be obtained at specific time points throughout the study. The pharmacokinetic samples will be collected on days 1, 4 through 8 and 9. | On therapy evaluation on Day1~9. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety parameters (Incidence of AEs and SAEs, Deaths, Premature discontinuation due to an AE, regardless of relationship to study medication; Clinical lab data; Vital signs; ECG; Physical exam findings; Concomitant medications and adjunctive procedures). | On therapy evaluation on Day1~9. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gang Chen, MD | AZ Pharmaceuticals - China | Study Chair |
| Haiyan Li, MD | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | China |
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| ID | Term |
|---|---|
| D017576 | Daptomycin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
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| D008055 |
| Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |