Effect of 50 and 750 mg of avasimibe oral dosing on midazolam pharmacokinetic parameters Sixteen subjects received 2 mg of oral midazolam before and on the 7th day of avasimibe 50 mg or 750 mg daily (eight subjects each). Plasma samples were collected and analyzed for midazolam concentrations as described under Materials and Methods.
Parameter | Midazolam | Midazolam + 50 mg Avasimibe | Midazolam + 750 mg Avasimibe | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Least-Squares Mean
|
Least-Squares Mean
|
Ratio
|
90% CI
|
Least-Squares Mean
|
Ratio
|
90% CI
| |||||
| n | 16 | 8 | 8 | ||||||||
| Cmax (μg/ml) | 5.92 | 2.52 | 42.6 | 33.8-53.7 | 1.06 | 17.9 | 14.2-22.5 | ||||
| Tmax (h) | 1.41 | 1.16 | 82.2 | N.A. | 0.781 | 55.6 | N.A. | ||||
|
AUC(0-tldc) (μg/h/ml)
|
21.2
|
5.74
|
27.1
|
19.1-38.4
|
1.38
|
6.49
|
4.57-9.20
| ||||
Ratio, ratio of treatment mean values expressed as a percentage (100%·test/reference); 90% CI, 90% confidence interval estimate for the ratio (test/reference) of treatment mean values, expressed as a percentage of the reference mean; N.A., not applicable.