Table V.
Pharmacokinetic parameters and 90% CIs* for the ratios of the geometric means of their log-transformed values for the 2 azithromycin capsule formulations (n = 12, where n is the number of volunteers).
| Pharmacokinetic Parameters | Test Formulation | Reference Formulation | P | T/R Point Estimate |
|---|---|---|---|---|
| Cmax (µg/mL) | ||||
| Mean (SD) | 0.34 (0.03) | 0.38 (0.04) | 0.06 | 0.88 |
| Range | 0.31–0.40 | 0.31–0.47 | 0.83–0.93* | |
| Median | 0.34 | 0.39 | ||
| %CV | 8.99 | 14.21 | ||
| Tmax (h) | ||||
| Mean (SD) | 2.83 (0.39) | 2.91 (0.29) | 0.56 | 0.97 |
| Range | 2.00–3.00 | 2.00–3.00 | 0.86–1.08* | |
| Median | 3.00 | 3.00 | ||
| %CV | 13.74 | 9.90 | ||
| AUC0–48 (h·µg/mL) | ||||
| Mean (SD) | 2.75 (0.46) | 2.85 (0.48) | 0.61 | 0.96 |
| Range | 2.00–3.76 | 2.14–3.55 | 0.85–1.10* | |
| Median | 2.72 | 2.87 | ||
| %CV | 16.74 | 16.26 | ||
| t1/2 (h) | ||||
| Mean (SD) | 9.20 (1.63) | 8.79 (1.02) | 0.47 | 1.05 |
| Range | 5.96–12.03 | 6.83–10.70 | 0.92–1.17* | |
| Median | 8.70 | 8.81 | ||
| MRT (h) | ||||
| Mean (SD) | 13.27 (2.35) | 12.68 (1.48) | 0.47 | 1.05 |
| Range | 8.60–17.35 | 9.85–15.5 | 0.92–1.16* | |
| Median | 12.55 | 12.70 | ||
| AUMC (h·µg/mL) | ||||
| Mean (SD) | 36.90 (11.02) | 36.57 (9.14) | 0.94 | – |
| Range | 23.98–61.34 | 21.08–50.82 | – | |
| Median | 33.31 | 36.76 |
AUMC = area under moment curve; CV = coefficient of variation; MRT = mean residence time; T/R = test/reference.