TABLE 7.
Summary of derived plasma ribavirin pharmacokinetic parameters in healthy participants with crystalline ribavirin-PRINT-IPa
| PK parameter (U) | Dose frequency, size (mg) | Visit (day) | N/n | Geometric mean | 95% CI | %CVb |
|---|---|---|---|---|---|---|
| Cohort A | ||||||
| AUC0−12 (h⋅ng/ml) | SD, 60 | 1 | 6/6 | 715 | 594–861 | 17.8 |
| SD, 120 | 3 | 6/6 | 1,490 | 1,140–1,950 | 25.8 | |
| BID, 30 | 6 | 6/6 | 578 | 464–721 | 21.3 | |
| Cmax (ng/ml) | SD, 60 | 1 | 6/6 | 232 | 188–287 | 20.2 |
| SD, 120 | 3 | 6/6 | 508 | 382–674 | 27.6 | |
| BID, 30 | 6 | 6/6 | 143 | 113–182 | 23.2 | |
| 19 | 6/6 | 194 | 166–227 | 15.1 | ||
| Tlast (h) | SD, 60 | 1 | 6/6 | 47.8 | ||
| SD, 120 | 3 | 6/6 | 71.8 | |||
| BID, 30 | 6 | 6/6 | 11.9 | |||
| 19 | 6/6 | 11.9 | ||||
| Tmax (h) | SD, 60 | 1 | 6/6 | 0.500 | 0.25–1.00 | |
| SD, 120 | 3 | 6/6 | 0.625 | 0.25–0.75 | ||
| BID, 30 | 6 | 6/6 | 0.500 | 0.50–0.75 | ||
| 19 | 6/6 | 0.500 | 0.25–0.50 | |||
| Cohort B | ||||||
| AUC0–τ (h⋅ng/ml) | BID, 60 | 1 | 12/12 | 565 | 418–763 | 50.2 |
| 14 | 12/8 | 2,060 | 1,820–2,340 | 15.2 | ||
| Cmax (ng/ml) | BID, 60 | 1 | 12/12 | 189 | 130–273 | 63.5 |
| 14 | 12/11 | 285 | 221, 367 | 39.0 | ||
| Tlast (h) | BID, 60 | 1 | 12/12 | 11.7 | 11.7–11.8 | |
| 14 | 12/11 | 11.7 | 11.7−12.0 | |||
| Tmax (h) | BID, 60 | 1 | 12 | 0.633 | 0.50–1.00 | |
| 14 | 11 | 0.500 | 0.30–1.00 | |||
a
Tmax and Tlast are expressed as medians and ranges, where appropriate. The Tlast ranges in cohort A are not presented since they were the same for all subjects at all times. Tau (τ) = 12 h, the dosing interval for the BID dosing regimen. SD, single dose, BD, twice daily. N, total number of participants; n, number of participants with observations.