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Table 3 Pharmacokinetic parameters for Posiphen and metabolites in plasma

From: A multicenter, randomized, double-blind, placebo-controlled ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effects of Posiphen in subjects with early Alzheimer’s Disease

Treatment arm

 

60 mg (n = 4)

60 mg BID (n = 5)

60 mg TID (n = 1)

Posiphen

AUC0 − 24 (hr*ng/mL)

212.32 (18.14)

195.80 (69.26)

288.25

Cmax (ng/mL)

52.70 (44.67)

30.39 (51.86)

51.80

Tmax (hr)

2 (2–2)

2 (2–12)

2

t1/2 (hr)

3.55 (48.65)

.

.

V/F (L)

1403.1 (59.23)

.

.

Cl/F (L/hr)

274.04 (17.50)

.

.

N1 metabolite

AUC0 − 24 (hr*ng/mL)

36.60 (19.24)

65.06 (58.61)

60.18

Cmax (ng/mL)

5.43 (21.98)

6.96 (32.01)

5.48

Tmax (hr)

2 (2–4)

12 (2–20)

2

N8 metabolite

AUC0 − 24 (hr*ng/mL)

66.02 (20.83)

113.65 (44.01)

80.40

Cmax (ng/mL)

6.81 (25.10)

10.01 (27.79)

5.41

Tmax (hr)

3 (3–4)

12 (2–20)

2

  1. AUC0 − 24, area under the concentration-time curve from 0 to 24 h; Cmax, maximum observed concentration; Tmax, time of maximum observed concentration; t1/2, terminal elimination half-life; V/F, apparent volume of distribution; Cl/F, apparent oral clearance. Data are presented as geometric mean (% geometric coefficient of variation) except Tmax which is presented as median (min-max). t1/2, V/F, and Cl/F are reported only for the 60 mg daily group