NCT02100917CompletedPhase 1
Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Meiji Seika Pharma Co., Ltd.
- Enrollment
- 70
- Primary Endpoint
- Maximum observed serum concentration (Cmax)
Study Overview
Brief Summary
This study is a randomized Trastuzumab-controlled double-blind parallel-group study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 39 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy Japanese male adults
- •Body Mass Index (BMI) between 17.6 and 26.4 kg/m² at the time of screening BMI = Body Weight (kg)/[Height (m)]²
- •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
- •History of hypersensitivity to components of Trastuzumab or diphenhydramine or any other drug
- •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)
- •History of allergic symptoms such as bronchial asthma and urticaria that would affect study participation in the opinion of the investigator or subinvestigators
- •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
Arms & Interventions
DMB-3111
Experimental
6 mg/kg is once given in intravenous drip infusion taking 90 min
Intervention: DMB-3111 (Drug)
trastuzumab
Active Comparator
6 mg/kg is once given in intravenous drip infusion taking 90 min
Intervention: trastuzumab (Drug)
Outcomes
Primary Outcomes
Maximum observed serum concentration (Cmax)
Time Frame: Day1-71
Area Under the Concentration-Time (AUC)
Time Frame: Day1-71
Secondary Outcomes
- Area under the concentration-time curve (AUC) from 0 to time of the last measurable concentration(Day1-71)
- Mean residence time (MRT) from 0 to infinity(Day1-71)
- Area under the concentration-time curve (AUC) from 0 to infinity(Day1-71)
- Time to reach the peak concentration (tmax)(Day1-71)
- Mean residence time (MRT) from 0 to final sampling time point(Day1-71)
- elimination rate constant (kel)(Day1-71)
- Incidence of adverse events(Day1-71)
- Elimination half life (t1/2)(Day1-71)
- Clearance (CL)(Day1-71)
Investigators
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