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A Randomized, Open Label, Single Dose Pharmacokinetic and Safety Study of Implantable Long Acting 3-month Naltrexone Subcutaneous Pellets Compared to Naltrexone IM Injection (Vivitrol) in Healthy Volunteers

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Trial Profile

A Randomized, Open Label, Single Dose Pharmacokinetic and Safety Study of Implantable Long Acting 3-month Naltrexone Subcutaneous Pellets Compared to Naltrexone IM Injection (Vivitrol) in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 18 Aug 2023

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At a glance

  • Drugs Naltrexone (Primary) ; Naltrexone
  • Indications Alcoholism; Opioid-related disorders
  • Focus First in man; Pharmacokinetics
  • Sponsors BioCorRx

Most Recent Events

  • 15 Aug 2023 According to a BioCorRx media release, the company is continue to work on fulfilling the requirements needed for New Drug Application (NDA) for full FDA marketing approval.
  • 14 Aug 2023 According to a BioCorRx media release, the company expect to receive a response to the FDA Fast Track application sometime next month
  • 18 Jul 2023 According to a BioCorRx media release, based on the positive interim results from this study the company submitted a fast track application to the U.S. Food and Drug Administration (FDA) for BICX104 and company is preparing to also apply for expanded access.

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