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A Phase 1b, Randomized 2-Part Single-Center Study to Evaluate the PK and Safety of Multiple Ascending Oral Doses of PF614 and the Food Effect and BA/BE of Single Oral Doses of PF614 Relative to OxyContin in Healthy Adult Subjects

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Trial Profile

A Phase 1b, Randomized 2-Part Single-Center Study to Evaluate the PK and Safety of Multiple Ascending Oral Doses of PF614 and the Food Effect and BA/BE of Single Oral Doses of PF614 Relative to OxyContin in Healthy Adult Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 30 Sep 2024

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At a glance

  • Drugs Oxycodone (Primary) ; PF 614 (Primary) ; Naltrexone
  • Indications Pain
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Ensysce Biosciences

    • Most Recent Events

    • 23 Jul 2024 According to an Ensysce Biosciences media release, results of clinical study P614-102 were published in an article.
    • 16 Sep 2022 Status changed from recruiting to completed.
    • 31 Mar 2022 According to an Ensysce Biosciences media release, the company concluded the clinical treatment of the Bioequivalence (BE) portion of the study on March 21, 2022.

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