Reference formulation, 200-mg Tablet
Pharmacokinetic parameters (no of subjects=8) Geometric Mean SD CV (%)
Cmax (mcg/ml) 1.82 0.19 10.70  
Tmax (hr) 2.00 0.92 48.80  
AUC0-24 (mcg.hr/ml) 12.56 0.96 7.70  
AUC0-∞ (mcg.hr/ml) 13.14 0.959 7.30  
T1/2 (hr) 5.55 0.715 12.90  
Kel (1/hr) 0.13 0.0174 13.40  
 
Test formulation, Oquin 200-mg Tablet
Pharmacokinetic parameters (no of subjects=8) Geometric Mean SD CV (%)
Cmax (mcg /ml) 1.98 0.21 10.80  
Tmax (hr) 2.00 0.53 26.50  
AUC0-24 (mcg.hr/ml) 13.19 1.45 11.00  
AUC0-∞ (mcg.hr/ml) 13.86 1.49 10.80  
T1/2 (hr) 5.55 1.37 24.80  
Kel (1/hr) 0.13 0.02 19.90  
Cmax (mcg /ml) =peak plasma concentration; Tmax (hr) =time to reach peak serum concentration; AUC0-24 (mcg.hr/ml) =the area under the serum concentration-time curve; AUC0-∞ (mcg.hr/ml) =the area under the serum concentration-time curve extrapolated to infinity; T1/2 (hr) =serum elimination half life; Kel (1/hr) =elimination rate constant; CV =coefficient of variation; SD =standard deviation

Table 3: Mean pharmacokinetic parameters of OFX 200-mg tablets

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