Table 4.

Mean N-desmethyl-sildenafil plasma concentrations after single-dose administration of test and reference doses of sildenafil citrate 50 mg (SILD-FMS-1002).

Parameter	Sildenafil citrate ODF without water (A) (n = 80)*	ViagraⓇ† FCT (B) (n = 80)*	Ratio A/B‡,§
CPEAK, ng/mL	35.50 (32.84)	37.91 (34.74)	0.961 (90.81–101.30)
AUCL, ng/hr/mL	173.5 (37.48)	172.8 (38.66)	1.01 (99.40–102.59)
AUC∞, ng/hr/mL	192.9 (39.89)	192.2 (41.87)	–
KEL, h−1	0.1942 (18.91)	0.2002 (21.28)	–
t½, h	3.725 (23.60)	3.707 (36.39)	–
TPEAK, h	1.341 (40.35)	1.206 (46.27)	–

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 = e [LSMEAN of (LNA = Natural log transformed sildenafil citrate ODF with water–LNB = Natural log transformed sildenafil citrate ODF without water)].