Clinical trial · Interventional
Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults
NCT02100917CI-TRIAL-00016827completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a randomized Trastuzumab-controlled double-blind parallel-group study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Volunteer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DMB-3111 | Drug | Trastuzumab | ALIAS |
| trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DMB-3111
- description
- 6 mg/kg is once given in intravenous drip infusion taking 90 min
- interventionNames
- Drug: DMB-3111
- type
- ACTIVE_COMPARATOR
- label
- trastuzumab
- description
- 6 mg/kg is once given in intravenous drip infusion taking 90 min
- interventionNames
- Drug: trastuzumab
Primary outcomes (2)
- measure
- Area Under the Concentration-Time (AUC)
- timeFrame
- Day1-71
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
- Maximum age
- 39 Years
Show eligibility criteria text
Inclusion Criteria: 1. Healthy Japanese male adults 2. Body Mass Index (BMI) between 17.6 and 26.4 kg/m² at the time of screening BMI = Body Weight (kg)/\[Height (m)\]² 3. The individual who freely consents to participate after receiving a detailed explanation of the clinical study and completely understanding thereof, and who has capacity to follow precautions and provide written consent. Exclusion Criteria: 1. History of hypersensitivity to components of Trastuzumab or diphenhydramine or any other drug 2. Use of any ethical drug within 2 weeks before investigational product administration or any over-the-counter drug within 1 week before investigational product administration that would affect study participation in the opinion of the investigator or subinvestigators (except for diphenhydramine, which will be used concomitantly in the present clinical trial and any drug applied locally and having no systemic actions) 3. History of allergic symptoms such as bronchial asthma and urticaria that would affect study participation in the opinion of the investigator or subinvestigators 4. History of cardiac disorders, hypertension, coronary artery disease (e.g., myocardial infarction, angina), and/or vascular disorder; ongoing palpitations, shortness of breath, and/or tachycardia
References
Publications (1)
- DERIVEDMorita 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. PMID 26691837