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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142486 | Registry Identifier | Japan Primary Registries Network |
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| Name | Class |
|---|---|
| Dong-A Pharmaceutical | INDUSTRY |
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This study is a randomized Trastuzumab-controlled double-blind parallel-group study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMB-3111 | Experimental | 6 mg/kg is once given in intravenous drip infusion taking 90 min |
|
| trastuzumab | Active Comparator | 6 mg/kg is once given in intravenous drip infusion taking 90 min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMB-3111 | Drug |
| ||
| trastuzumab |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time (AUC) | Day1-71 | |
| Maximum observed serum concentration (Cmax) | Day1-71 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC) from 0 to time of the last measurable concentration | Day1-71 | |
| Area under the concentration-time curve (AUC) from 0 to infinity | Day1-71 | |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of anti-trastuzumab antibodies (ADAs) | Day1-71 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka | Fukuoka | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26691837 | Derived | Morita J, Tanaka M, Nomoto M, Matsuki S, Tsuru T, Matsuguma K, Shiramoto M. Pharmacokinetic Bioequivalence, Safety, and Immunogenicity of DMB-3111, a Trastuzumab Biosimilar, and Trastuzumab in Healthy Japanese Adult Males: Results of a Randomized Trial. BioDrugs. 2016 Feb;30(1):17-25. doi: 10.1007/s40259-015-0153-2. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Time to reach the peak concentration (tmax) |
| Day1-71 |
| Mean residence time (MRT) from 0 to final sampling time point | Day1-71 |
| Mean residence time (MRT) from 0 to infinity | Day1-71 |
| elimination rate constant (kel) | Day1-71 |
| Elimination half life (t1/2) | Day1-71 |
| Clearance (CL) | Day1-71 |
| Incidence of adverse events | Day1-71 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |