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
Latest Information Update: 21 Sep 2022
At a glance
- Drugs Oxycodone (Primary) ; PF 614 (Primary) ; Naltrexone
- Indications Pain
- Focus Adverse reactions; Pharmacokinetics
- Sponsors Ensysce Biosciences
- 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.
- 10 Jan 2022 According to an Ensysce Biosciences media release,the BE study follows the successful completion of the multi-ascending twice daily dosing study of PF614.