A Randomized, Open-label, 2-arm, Parallel Group, Single Dose, Multi-center Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of Trastuzumab Administered Subcutaneously as the Trastuzumab/rHuPH20 Formulation Using a Handheld Syringe or Using the Proprietary Single-use Injection Device (SID).

Trial Profile

A Randomized, Open-label, 2-arm, Parallel Group, Single Dose, Multi-center Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of Trastuzumab Administered Subcutaneously as the Trastuzumab/rHuPH20 Formulation Using a Handheld Syringe or Using the Proprietary Single-use Injection Device (SID).

Completed
Phase of Trial: Phase I

Latest Information Update: 15 Sep 2015

At a glance

  • Drugs Trastuzumab (Primary)
  • Indications Breast cancer; Gastric cancer
  • Focus Pharmacokinetics
  • Sponsors Roche
  • Most Recent Events

    • 23 May 2013 Actual initiation date changed from Mar 2012 to Jan 2012 as reported by ClinicalTrials.gov.
    • 18 Apr 2012 Actual end date (Mar 2012) added as reported by ClinicalTrials.gov.
    • 15 Feb 2012 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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