Table 2.
Mean N-desmethyl-sildenafil plasma concentrations after single-dose administration of test and reference doses of sildenafil citrate 50 mg (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 | 15.85 (55.82) | 15.59 (43.86) | 15.95 (48.88)¶ | 0.96 (87.36–105.38) | 0.95 (81.78–111.19) |
| AUCL, ng/hr/mL | 67.15 (43.74) | 66.55 (42.00) | 63.84 (36.95)¶ | 1.01 (96.39–104.87) | 0.94 (75.58–117.37) |
| AUC∞, ng/hr/mL | 74.18 (40.26) | 75.58 (35.80)¶ | 70.30 (33.28)¶ | – | – |
| KEL, h−1 | 0.2076 (21.20) | 0.2121 (24.85)¶ | 0.2118 (19.70)¶ | – | – |
| t½, h | 3.492 (21.89) | 3.529 (34.62)¶ | 3.406 (20.81)¶ | – | – |
| TPEAK, h | 1.064 (49.56) | 1.269 (72.56) | 1.220 (52.16)¶ | – | – |
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.