Table 1.
Descriptive summary of plasma sildenafil pharmacokinetic parameters after a single oral dose of 50 mg sildenafil citrate (SILD-FMS-1001).
| Parameter | Sildenafil citrate ODF with water (A) (n = 41)* |
Sildenafil citrate ODF without water (B) (n = 41)* |
ViagraⓇ† FCT (C) (n = 42)* |
...Ratio (A/C)* |
Ratio (B/C)‡,|| |
|---|---|---|---|---|---|
| CPEAK, ng/mL | 182.7 (46.72) | 201.3 (47.66) | 181.3 (57.40 | 1.02 (94.91–108.78) | 1.07 (91.26–125.95) |
| AUCL, ng/hr/mL | 578.3 (40.89) | 628.9 (40.05) | 525.3 (38.22) | 1.09 (104.49–113.21) | 1.12 (94.39–132.92) |
| AUC∞, ng/hr/mL | 606.2 (41.61)¶ | 668.0 (36.16)¶ | 547.4 (37.72) | – | – |
| KEL, h−1 | 0.2816 (31.11)¶ | 0.2929 (28.58)¶ | 0.2024 (34.11) | – | – |
| t½, h | 2.707 (31.35)¶ | 2.591 (33.21)¶ | 2.652 (34.04) | – | – |
| TPEAK, h | 1.044 (44.69) | 1.338 (66.19) | 1.188 (44.15) | – | – |
AUC... = area under the plasma concentration-time curve from zero to infinity; AUCL = area under the plasma concentration-time curve; CPEAK = maximum plasma concentration; FCT = film coated tablet; KEL = elimination rate constant; ODF = orally disintegrating film; TPEAK = time to CPEAK.
Values are presented as arithmetic mean (% coefficient of variation).
Pfizer Inc, New York, New York.
Ratio of geometric least-squares means (90% CI, used as natural log transformed parameter).
§Ratio (A/C) = e [LSMEAN of (LNA = Natural log transformed sildenafil citrate ODF with water – LNC = Natural log transformed Viagra FCT).
Ratio (B/C) = e [LSMEAN of (LNB = Natural log transformed sildenafil citrate ODF without water – LNC = Natural log transformed Viagra FCT)].
n=39.