Table 2 Summary of the study designs and population demographics of selected (S)-(nor)ketamine PK models from literature. CRPS-1 complex regional pain syndrome type 1

From: Predictive performance of parent-metabolite population pharmacokinetic models of (S)-ketamine in healthy volunteers

  Sigtermans et al. [18] Dahan et al. [30] Noppers et al. [31] Fanta et al. [27] Jonkman et al. [26]
Study design
Administered drug (S)-ketamine (S)-ketamine (S)-ketamine (S)-ketamine (S)-ketamine
Mode of administration Intravenous infusion (2h) Intravenous infusion (100h) Intravenous infusion (2h) Intravenous bolus or oral dose Inhalations followed by intravenous infusion (0.33 h)
Dose 0.95 mg/kg 0.07 mg/kg/h to 0.29 mg/kg/h 0.57 mg/kg and 1.14 mg/kg Bolus: 0.125 mg/kg
Oral: 0.25 mg/kg
Inhalation: 25 - 37.5 - 50.0 mg or 25 - 50 - 100 mg
Infusion: 20 mg
PK-sampling schedule (h) 0.25 - 0.5 - 0.75 - 1 - 1.25 - 1.5 - 1.75 - 2 - 2.03 - 2.08 - 2.17 - 2.25 - 2.5 - 2.75 - 3 - 3.25 - 3.5 - 4 - 4.5 - 5 4 times a day, at change of infusion or at random 0 - 0.08 - 0.17 - 0.25 - 0.5 - 0.75 - 1 - 1.25 - 1.
5 - 1.75 - 2 - 2.08 - 2.16 - 2.25 - 2.5 - 3 - 3.5 - 4 - 4.5 - 5
0.04 - 0.08 - 0.17 - 0.25 - 0.33 - 0.5 - 0.75 - 1 - 1.5 - 2 - 4 - 6 - 8 - 12 - 23.5 0.03 - 0.07 - 0.13 - 0.17 - 0.25 - 0.33 - 0.37 - 0.4 - 0.5 - 0.67 - 1 -1.33 - 2 - 3
Sampling methodology Arterial Venous Arterial Venous Arterial
Demographics
Population Healthy volunteers CRPS-1 patients Healthy volunteers Healthy volunteers Healthy volunteers
N (male) 20 (10) 30 (8) 20 (20) 11 (11) 19 (10)
Age (year) 21.7 ± 0.5 46 ± 12 22.0 (20-29) 22.3 ± 2.4 24 ± 2
BMI (kg/m2) 22.1 ± 0.5 n/a 22.2 (19-28) 23.6 ± 1.8 22 ± 2
Weight (kg) 69.4 ± 2.4 79 ± 19 Not reported 77 ± 7.5 Not reported