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The purpose of this study is to evaluate the pharmacokinetic similarity of bevacizumab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of bevacizumab with different manufacturing process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bevacizumab with old manufacturing process. | Active Comparator |
| |
| bevacizumab with new manufacturing process. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab with new manufacturing process. | Drug | 3mg/kg,I.V.,single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure:Area Under the Curve(AUC0-∞) | 84days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve(AUClast) | 84days | |
| Maximum Concentration (Cmax) | 84days | |
| Volume of distribution (V) |
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Inclusion Criteria:
Exclusion Criteria:
Age≥18 years and ≤50 years, healthy male subjects
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Soochow university | Suzhou | Jiangsu | 215006 | China |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| bevacizumab with old manufacturing process. | Drug | 3mg/kg,I.V.,single dose |
|
| 84days |
| Total body clearance (CL) | 84days |
| Elimination half-life (t1/2) | 84days |
| Time at which maximum concentration occurred (Tmax) | 2016days |
| Incicende of Adverse Events (AEs) | 98days |
| Anti-drug Antibody(ADA)and Neutralizing Antibody(NAb) | 98days |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |