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583 : A pharmacokinetics (PK) bioequivalence trial of proposed trastuzumab biosimilar, Myl-1401O (A) vs EU-Herceptin (B) and US-Herceptin (C).

Researchers

Presenter

  • Cornelius F. Waller

Principal Investigators

  • Apinya Vutikullird

  • Tracey E. Lawrence

  • Andrew Shaw

  • Mark Shiyao Liu

  • Mark Baczkowski

  • Rajiv Sharma

  • Abhijit Barve

  • Eduardo J. Pennella

Medical Centers

  • University of Freiburg Medical Center, Freiburg, Germany

  • West Coast Clinical Trials Global, Cypress, CA

  • Mylan, Morgantown, WV

  • Mylan, Hatfield, United Kingdom

  • Head of Global Clinical Research, Mylan, Canonsburg, PA

  • Mylan, Canonsburg, PA

Locations

  • United States

  • Germany

  • United Kingdom

Companies

  • N/A

Study Components

Therapeutic Area

  • N/A

Disease

  • N/A

Biomarkers

  • N/A

Drug/Treatment

  • Trastuzumab biosimilar

  • CT-P6

  • Trastuzumab

Outcome

  • N/A

Study Design

  • Randomized

  • Pharmacokinetics

  • Double Blind/Blinded

  • Multiple Arm

  • Parallel Group

  • Single Center

Phase

  • I

Study Id's

  • NCT02594761

Sponsors

  • N/A

Result

  • Final

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