TABLE 1.
Summary of study design and demographicsa
| Characteristic | Phase 2a study |
Phase 2b study (3rd trial) | ||
|---|---|---|---|---|
| 1st trial | 2nd trial | 1st and 2nd trials | ||
| No. of patients | 31 | 37 | 125 | |
| Dose | 200 mg (n = 13), 400 mg (n = 9), 600 mg (n = 9) | 25 mg (n = 9), 50 mg (n = 9), 100 mg (n = 9), 200 mg (n = 10) | 400 mg (n = 123), 200 mg (n = 2, wrong dose) | |
| Formulation | 200-mg tablets | 50-mg tablets | 200-mg tablets | |
| Median (range) age (yr) | 42 (15–65) | 48 (15–79) | ||
| Median (range) wt (kg) | 52 (38–67) | 54 (32–85) | ||
| % (no.) of female subjects | 51 (35) | 54 (68) | ||
| Sampling scheme | Venous blood, 0, 1, 2, 3, 4, 4.5, 5, 6, 8, 10, and 24 h; DBS, 0, 1, 3, 4.5, 6, 10 h or 0, 2, 4, 5, 8, and 24 h | DBS, 0.33, 2, 7.75, 8, and 30 h | ||
| Covariates | Age, sex, ht, wt, temp, blood pressure, parasitology, pregnancy | Age, sex, ht, wt, temp, blood pressure, parasitology, pregnancy | ||
| Other clinical data | Renal and hepatic functions (azotemia, creatinine, ASAT-GOT, ALAT-GOT) | |||
a
DBS, dried blood spots; ASAT, aspartate aminotransferase; GOT, glutamic oxalacetic transaminase; ALAT, alanine aminotransferase.