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Assessment of cetrorelix pamoate intermittent IM administration on ECG, PK and PD parameters in healthy male volunteers - a Thorough QT assesment to address the ICH-E14 guidelines

Trial Profile

Assessment of cetrorelix pamoate intermittent IM administration on ECG, PK and PD parameters in healthy male volunteers - a Thorough QT assesment to address the ICH-E14 guidelines

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 14 Mar 2011

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At a glance

  • Drugs Cetrorelix (Primary) ; Moxifloxacin
  • Indications Bacterial infections; Benign prostatic hyperplasia
  • Focus Adverse reactions
  • Sponsors AEterna Zentaris Inc; Celerion

Most Recent Events

  • 05 Mar 2011 Pharmacokinetic and pharmacodynamic results presented at the 112th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
  • 08 Oct 2009 New trial record.
  • 30 Sep 2009 Primary endpoint 'no increase in heart rate-corrected QT interval' has been met.

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