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An Adaptive, Randomized, Double-blind, Single-center, Placebo-controlled Phase I Study Evaluating ECG Effects, Safety and Pharmacokinetics of Single Ascending Doses of [6R]-5,10-Methylene Tetrahydrofolate (Modufolin® for Injection, 100mg) in Healthy Male Volunteers

Trial Profile

An Adaptive, Randomized, Double-blind, Single-center, Placebo-controlled Phase I Study Evaluating ECG Effects, Safety and Pharmacokinetics of Single Ascending Doses of [6R]-5,10-Methylene Tetrahydrofolate (Modufolin® for Injection, 100mg) in Healthy Male Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 13 Oct 2017

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At a glance

  • Drugs Arfolitixorin (Primary)
  • Indications Colorectal cancer; Folic acid deficiency; Rectal cancer
  • Focus Adverse reactions
  • Sponsors Isofol Medical
  • Most Recent Events

    • 10 Oct 2017 Status changed from recruiting to completed.
    • 05 Jul 2017 According to an Isofol Medical media release, the first six patients have been enrolled and dosed in this study. This study is part of the regulatory documentation required for an oncology drug to be granted approval.
    • 05 Jul 2017 Status changed from not yet recruiting to recruiting according to an Isofol Medical media release.
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