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Clinical Trials/NCT02100917
NCT02100917CompletedPhase 1

Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults

Meiji Seika Pharma Co., Ltd.0 sites70 target enrollmentStarted: January 2014Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
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

Sponsor Class
Industry
Responsible Party
Sponsor

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