Parameter | Clofazimine (Mean ± S.D.) | |
---|---|---|
Oral Dose (50 mg) | Oral Dose (100 mg) | |
Cmax (ng/ml) | ||
Observeda | 71.8 ± 34.1 | 131 ± 59.9 |
Predicted | 83.3 ± 219 | 178 ± 465 |
PE (%)b | +16% | +36% |
AUC0–24 h (ng⋅h/ml) | ||
Observeda | 1084 ± 409 | 1856 ± 821 |
Predicted | 976 ± 1633 | 2090 ± 3691 |
PE (%)b | −10% | +13% |
Tmax (h)c | ||
Observeda | 8 | 6 |
Predicted | 9.5 | 9.5 |
PE (%)b | +19% | +58% |
AUC0–24 h, area under plasma-drug concentration curve between 0 and 24 hours; PE, prediction error (%); Tmax, time to reach maximum concentration.
↵a Clinical PK parameters were not available on day 43; hence, the day 1 PK parameters were used for comparison; picomoles per grams was converted to nanograms per milliliter as follows: pmol/g = (pmol/g) × molecular weight (g/mol) = pmol/mol = ng/g = ng/ml, where plasma density assumes a value of ∼1 g/ml.
↵b Prediction error = [(predicted value − observed value)/observed value] × 100.
↵c Median.