TABLE 3.
Results of the bioequivalence determination of Cefaclor granule and Cefaclor suspension in fasting sequence.
| PK parameter | Geometric mean | GMR (%) | 90% CI (%) | %CV | Power | Result | |
|---|---|---|---|---|---|---|---|
| Cmax (ng/mL) | T (N = 22) | 6272.71 | 93.01 | 85.96–100.63 | 15.18 | 93.78 | Bioequivalent |
| R (N = 22) | 6744.49 | ||||||
| AUC0-t (h*ng/mL) | T (N = 22) | 5383.22 | 97.92 | 96.49–99.38 | 2.83 | >99.99 | |
| R (N = 22) | 5497.41 | ||||||
| AUC0-∞ (h*ng/mL) | T (N = 22) | 5409.02 | 97.95 | 96.52–99.41 | 2.82 | >99.99 | |
| R (N = 22) | 5522.09 | ||||||
T, test drug was Cefaclor granule; R, reference drug was Cefaclor suspension; PK, Pharmacokinetic; N, number of subjects; GMR, geometric mean ratios; CI, confidence Interval; CV%, within-subject coefficient of variation; AUC 0-t, the AUC of the analyte in the plasma over the time interval from time zero to the last measurable concentration; AUC0-∞, the area under the curve from 0 to infinity; Cmax, the maximum observed drug concentration in the plasma.