Table 2.
Statistical analysis of L‐PZQ AUC 0‐∞ (EMR 200585‐001 and EMR 200661‐001; PK populations)
| Parameter (h*ng/mL) | Treatment | N | Geo‐LS mean | Test/reference ratio (%) | 90% CI of ratio | CV(%) |
|---|---|---|---|---|---|---|
| EMR 200585001 | ||||||
| AUC0‐∞ | A (ODT rac‐PZQ 40 mg/kg dispersed in water; fed) | 30 | 2,017.268 | 96.2 | 83.9–110.2 | 32.5 |
| B (Cysticide 40 mg/kg given with water; fed) | 30 | 2,047.876 | ||||
| AUC0‐∞ | C1 (ODT rac‐PZQ 20 mg/kg dispersed in water; fed) | 14 | 371.0268 | 18.4 | 15.3–22.0 | 32.5 |
| A (ODT rac‐PZQ 40 mg/kg dispersed in water; fed) | 30 | 2,017.268 | ||||
| AUC0‐∞ | C2 (ODT rac‐PZQ 60 mg/kg dispersed in water; fed) | 15 | 4,492.878 | 222.7 | 186.8–265.6 | 32.5 |
| A (ODT rac‐PZQ 40 mg/kg dispersed in water; fed) | 30 | 2,017.268 | ||||
| AUC0‐∞ | A (ODT rac‐PZQ 40 mg/kg dispersed in water; fed) | 30 | 2,017.268 | 238.1 | 198.7–285.3 | 32.5 |
| D1 (ODT rac‐PZQ 40 mg/kg dispersed in water; fasted) | 14 | 847.2601 | ||||
| AUC0‐∞ | D2 (Cysticide 40 mg/kg as crushed tablets; fed) | 14 | 1,721.742 | 82.1 | 68.5–98.3 | 32.5 |
| B (Cysticide 40 mg/kg given with water; fed) | 30 | 2,097.487 | ||||
| EMR 200661001 | ||||||
| AUC0‐∞ | A (ODT L‐PZQ 20 mg/kg dispersed in water; fed) | 36 | 825.2068 | 39.9 | 34.7–46.0 | 36.8 |
| B (Cysticide 40 mg/kg given with water; fed) | 36 | 2,066.002 | ||||
| AUC0–∞ | C1 (ODT L‐PZQ 10 mg/kg dispersed in water; fed) | 17 | 225.5903 | 27.3 | 22.5–33.2 | 39.2 |
| A (ODT L‐PZQ 20 mg/kg dispersed in water; fed) | 36 | 825.2068 | ||||
| AUC0‐∞ | C2 (ODT L‐PZQ 30 mg/kg dispersed in water; fed) | 17 | 2,147.473 | 260.2 | 214.0–316.4 | 39.2 |
| A (ODT L‐PZQ 20 mg/kg dispersed in water; fed) | 36 | 825.2068 | ||||
| AUC0‐∞ | A (ODT L‐PZQ 20 mg/kg dispersed in water; fed) | 36 | 825.2068 | 167.1 | 143.9–194.0 | 39.2 |
| D (ODT L‐PZQ 20 mg/kg dispersed in water; fasted) | 35 | 493.9041 | ||||
| AUC0–∞ | E (ODT L‐PZQ 20 mg/kg directly disintegrated in the mouth without water; fed) | 36 | 954.5461 | 115.7 | 99.8–134.1 | 39.2 |
| A (ODT L‐PZQ 20 mg/kg dispersed in water; fed) | 36 | 825.2068 | ||||
AUC0–∞, area under the plasma concentration‐time curve from zero to infinity (adjusted to planned dose); CI, confidence interval; CV%, coefficient of variability percentage; EMR, electronic medical record; Geo‐LSMean, geometric least squares mean; L‐PZQ, levo‐praziquantel; N, number of subjects included in the analysis; ODT, orally dispersible tablet; PK, pharmacokinetic; rac‐PZQ, racemate praziquantel.