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To determine the pharmacokinetic bioequivalence of DMB-3113 and adalimumab and to confirm the safety of the study drug in healthy Japanese adult male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMB-3113 | Experimental | adalimumab biosimilar |
|
| adalimumab | Active Comparator | adalimumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMB-3113 | Drug | subcutaneously injected in a single dose of 40 mg. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum concentration-time curve (AUC) from 0 to final sampling time point | Day 1 to Day 71 | |
| AUC from 0 to infinity | Day 1 to Day 71 | |
| Maximum serum concentration (Cmax) | Day 1 to Day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC from 0 to the last measurable concentration | Day 1 to Day 71 | |
| Time to reach the peak concentration (tmax) | Day 1 to Day 71 | |
| Mean residence time (MRT) from 0 to final sampling time point |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hideki Fushimi, Manager | Meiji Seika Pharma Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka | Japan |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Adalimumab |
| Drug |
subcutaneously injected in a single dose of 40 mg. |
|
| Day 1 to Day 71 |
| MRT from 0 to infinity | Day 1 to Day 71 |
| Elimination rate constant (kel) | Day 1 to Day 71 |
| Elimination half life (t1/2) | Day 1 to Day 71 |
| Observed clearance (CL/F) | Day 1 to Day 71 |
| Observed volume of distribution (V/F) | Day 1 to Day 71 |
| Incidence of adverse events | Day 1 to Day 71 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |