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 |