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Table 1 Pharmacokinetic parameters of phenobarbital following oral administration of 100 mg Luminal® vet or Phenoleptil® in a group of 8 dogs

From: Is switching from brand name to generic formulations of phenobarbital associated with loss of antiepileptic efficacy?: a pharmacokinetic study with two oral formulations (Luminal® vet, Phenoleptil®) in dogs

Parameter Luminal® vet Phenoleptil® P
Tmax (h) observed 3.75 ± 0.79 2.75 ± 0.37 0.2275
Tmax (h) calculated 5.97 ± 1.33 2.64 ± 0.51 0.0588
Cmax (μg/ml) observed 10.9 ± 0.92 10.5 ± 0.77 0.2426
Cmax (μg/ml) calculated 10.3 ± 0.92 10.0 ± 0.85 0.2569
T0.5 (h) 50.3 ± 3.1 52.9 ± 2.8 0.2348
AUC(0-119) (μg ml-1 h) observed 644 ± 52.5 618 ± 44.5 0.1499
AUC∞ (μg ml-1 h) calculated 807 ± 66.8 781 ± 54.0 0.2961
Relative bioavailability (AUCPhenoleptil® /AUCLuminal® vet) 0.98 ± 0.031
(range: 0.90-1.15; 90% CI: 0.92-1.04)
Relative Cmax observed (Cmax, observed Phenoleptil®/ Cmax, observed Luminal® vet) 0.96 ± 0.031
(range: 0.85-1.05; 90% CI: 0.90-1.03)
Relative Cmax calculated (Cmax, calculated, Phenoleptil®)/Cmax, calculated, Luminal® vet) 0.97 ± 0.028
  (range: 0.81-1.08; 90% CI: 0.92-1.03)
  1. All data are shown as means ± SEM; for ratios also the range and 90% confidence intervals (90% CI) are shown. Abbreviations: Tmax, time to reach peak plasma concentration; Cmax, peak plasma concentration; t0.5, elimination half-life in plasma; AUC, area under the plasma concentration curve.