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The goal of this clinical trial is to evaluate the Epithelial Lining Fluid concentrations and permeability of Intravenous Meropenem-Pralubactam(Meropenem/FL058) in China Healthy Adult Participants. The main question it aims to answer is:
• [question 1] : What are the concentrations of meropenem and Pralubactam in plasma, epithelial lining fluid (ELF), and alveolar macrophages (AM) at each time point
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Meropenem-Pralubactam | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meropenem-Pralubactam | Drug | The study is designed to enroll approximately 16 healthy participants. The study will evaluate the plasma, epithelial lining fluid, and alveolar macrophage concentrations of Meropenem-Pralubactam |
| Measure | Description | Time Frame |
|---|---|---|
| CPlasma、CELF、CAM | Assessment of plasma, ELF and AM concentrations of Intravenous Meropenem-Pralubactam after 4 doses of Meropenem-Pralubactam | 5 days |
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Inclusion Criteria:
Male or female, aged 18-45 years
Body mass index (BMI): 19-28 kg/m² , with body weight ≥50 kg.
Pulmonary function at screening:
Participant capability:
Reproductive planning:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pinfang Huang, bachelor | Contact | 0591- 87981331 | 2363869908@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | China |
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| ID | Term |
|---|---|
| D007239 | Infections |
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