Table 5 Comparative pharmacokinetic characteristics of Eperisone 150 mg after administration of immediate release conventional tablets (Reference) and osmotic pump dosage form (Test) in 12 healthy human subjects with geometric mean ratio and 90% CIs.
Type of dosage Form | Cmax (ng/ml) | Tmax (hr) | AUC0-t (h.ng/ml) | AUC0-∞ (h.ng/ml) | t1/2ʎz (h) | Vz/F (L) | Cl/F (L/h) | MTT (h) | |
|---|---|---|---|---|---|---|---|---|---|
Immediate release (Reference = R) | Mean | 7.65 | 1.02 | 20.67 | 20.88 | 1.81 | 18800 | 7211 | 2.94 |
SD | 1.28 | 0.24 | 1.32 | 1.33 | 0.09 | 1690 | 450 | 0.26 | |
%CV | 16.78 | 23.36 | 6.4 | 6.38 | 5.14 | 8.99 | 6.24 | 8.91 | |
Min | 5.8 | 0.75 | 18.69 | 18.96 | 1.67 | 16815 | 6361 | 2.56 | |
Max. | 9.95 | 1.5 | 23.34 | 23.58 | 1.99 | 22755 | 7911 | 3.39 | |
Osmotic pump (Test = T) | Mean | 3.46 | 4.83 | 22.85 | 22.91 | 1.99 | 18982 | 6585 | 7.24 |
SD | 0.33 | 1.21 | 1.67 | 1.67 | 0.15 | 2491 | 522 | 0.42 | |
%CV | 9.49 | 25.1 | 7.32 | 7.29 | 7.57 | 13.12 | 7.93 | 5.86 | |
Min | 2.95 | 3 | 19.32 | 19.39 | 1.69 | 15054 | 5948 | 6.51 | |
Max. | 4.01 | 6 | 25.17 | 25.22 | 2.17 | 24100 | 7735 | 7.78 | |
Geometric Mean Ratio(T/R) | 0.46 | 4.69 | 1.1 | 1.08 | 1.1 | 0.91 | 1 | 2.47 | |
90% CI | 0.41–0.51 | 3.74–5.89 | 1.05–1.16 | 1.03–1.14 | 1.04–1.16 | 0.85–0.98 | 0.90–1.12 | 2.36–2.59 | |
