Journal: Clinical and Translational Science

Article Title: Clinical evaluation of PF614, a novel TAAP prodrug of oxycodone, versus OxyContin in a multi‐ascending dose study with a bioequivalence arm in healthy volunteers

doi: 10.1111/cts.13765

Figure Lengend Snippet: Summary of oxycodone plasma PK parameters following PF614 and OxyContin administration (day 1) – part A.

Article Snippet: The ER oxycodone hydrochloride (OxyContin; Purdue Pharma) was supplied as 20 and 40 mg tablets that were obtained from commercial sources (Lots WP5J1 and WK8P0A [20 mg] and WM2E1 [40 mg]).

Techniques: Clinical Proteomics

Journal: Clinical and Translational Science

Article Title: Clinical evaluation of PF614, a novel TAAP prodrug of oxycodone, versus OxyContin in a multi‐ascending dose study with a bioequivalence arm in healthy volunteers

doi: 10.1111/cts.13765

Figure Lengend Snippet: Part A: Semi‐log plot of mean (SD) oxycodone plasma concentrations versus time. Part A: day 1 0–12 h; Part B: day 5 0–120 h. Mean plasma concentrations of plasma oxycodone on day 1 (a) versus day 5 (b) are shown following single oral dose administrations of 50 mg, 100 mg, or 200 mg PF614, or 20 mg, 40 mg, or 100 mg OxyContin. PK concentrations were collected for 18 subjects in the PF614 group (6 subjects in each dose cohort) or six subjects in the OxyContin group (2 subjects in each dose cohort). Oxycodone mean plasma concentrations were above the LLOQ (0.200 ng/mL) within 0.50 h to 1.00 h postdose. LLOQ, lower limit of quantification; PK, pharmacokinetic.

Article Snippet: The ER oxycodone hydrochloride (OxyContin; Purdue Pharma) was supplied as 20 and 40 mg tablets that were obtained from commercial sources (Lots WP5J1 and WK8P0A [20 mg] and WM2E1 [40 mg]).

Techniques: Clinical Proteomics

Journal: Clinical and Translational Science

Article Title: Clinical evaluation of PF614, a novel TAAP prodrug of oxycodone, versus OxyContin in a multi‐ascending dose study with a bioequivalence arm in healthy volunteers

doi: 10.1111/cts.13765

Figure Lengend Snippet: Summary of oxycodone plasma trough concentrations – part A.

Article Snippet: The ER oxycodone hydrochloride (OxyContin; Purdue Pharma) was supplied as 20 and 40 mg tablets that were obtained from commercial sources (Lots WP5J1 and WK8P0A [20 mg] and WM2E1 [40 mg]).

Techniques: Clinical Proteomics

Journal: Clinical and Translational Science

Article Title: Clinical evaluation of PF614, a novel TAAP prodrug of oxycodone, versus OxyContin in a multi‐ascending dose study with a bioequivalence arm in healthy volunteers

doi: 10.1111/cts.13765

Figure Lengend Snippet: Summary of oxycodone plasma pharmacokinetic parameters: part B.

Article Snippet: The ER oxycodone hydrochloride (OxyContin; Purdue Pharma) was supplied as 20 and 40 mg tablets that were obtained from commercial sources (Lots WP5J1 and WK8P0A [20 mg] and WM2E1 [40 mg]).

Techniques: Clinical Proteomics

Journal: Clinical and Translational Science

Article Title: Clinical evaluation of PF614, a novel TAAP prodrug of oxycodone, versus OxyContin in a multi‐ascending dose study with a bioequivalence arm in healthy volunteers

doi: 10.1111/cts.13765

Figure Lengend Snippet: Statistical analysis of bioequivalence on oxycodone for PF614 versus OxyContin: part B.

Article Snippet: The ER oxycodone hydrochloride (OxyContin; Purdue Pharma) was supplied as 20 and 40 mg tablets that were obtained from commercial sources (Lots WP5J1 and WK8P0A [20 mg] and WM2E1 [40 mg]).

Techniques:

Journal: Clinical and Translational Science

Article Title: Clinical evaluation of PF614, a novel TAAP prodrug of oxycodone, versus OxyContin in a multi‐ascending dose study with a bioequivalence arm in healthy volunteers

doi: 10.1111/cts.13765

Figure Lengend Snippet: Part B: scatter plot of individual oxycodone. Part A: C max and B: AUC 0–inf values. Individual subject ( n = 57) C max (a) or AUC 0–inf (b) values are plotted for 100 mg PF614 or 40 mg OxyContin dose groups administered in the fed and fasted state. Mean (filled bar) and median (open bar) values are shown for each group. BE between groups is demonstrated by the BE brackets. AUC 0–inf , area under the curve from 0 to infinity; BE, bioequivalence; C max , maximal plasma concentration.

Article Snippet: The ER oxycodone hydrochloride (OxyContin; Purdue Pharma) was supplied as 20 and 40 mg tablets that were obtained from commercial sources (Lots WP5J1 and WK8P0A [20 mg] and WM2E1 [40 mg]).

Techniques: Clinical Proteomics, Concentration Assay

Journal: Clinical and Translational Science

Article Title: Clinical evaluation of PF614, a novel TAAP prodrug of oxycodone, versus OxyContin in a multi‐ascending dose study with a bioequivalence arm in healthy volunteers

doi: 10.1111/cts.13765

Figure Lengend Snippet: Statistical analysis of food effects on oxycodone bioavailability following oral PF614 or OxyContin: part B.

Article Snippet: The ER oxycodone hydrochloride (OxyContin; Purdue Pharma) was supplied as 20 and 40 mg tablets that were obtained from commercial sources (Lots WP5J1 and WK8P0A [20 mg] and WM2E1 [40 mg]).

Techniques: