Table 1.

Single-dose pharmacokinetics of TFV and FTC in the test (T +PRO) and control (C -PRO) treatments represented as geometric mean (GM) or geometric mean ratio (GMR, T/C) and 90% confidence intervals (90% CI).

	Tenofovir (TFV)			Emtricitabine (FTC)
PK Parameters	C	T	GMR (T/C)	C	T	GMR (T/C)
Cmax (ng/mL)	529	538	1	3426	4108	1.2
	(464–602)	(502–577)	(0.91–1.1)	(3137–4806)	(3720–4535)	(1.0–1.4)
Tmax (h)*	1	1.5		2	2
	(1–4)	(1–2)		(1–4)	(1–4)
AUC0-INF (ng*h/mL)	3958	6444	1.6	20635	34030	1.6
	(3618–4331)	(5827–7127)	(1.5–1.8)	(18984–22431)	(30886–37494)	(1.5–1.9)
AUC0–24 (ng*h/mL)	3026	4963	1.6	19488	31482	1.6
	(2799–3271)	(4576–5385)	(1.5–1.8)	(17830–21300)	(28856–34346)	(1.4–1.8)
CL/F (L/h)	152	93	0.61	19	12	0.61
	(139–166)	(84–103)	(0.56–0.67)	(18–21)	(11–13)	(0.54–0.69)
kel (1/h)	0.055	0.059		0.1	0.099
	(0.050–0.60)	(0.054–0.064)		(0.087–0.12)	(0.090–0.11)
t1/2 (h)a	13	12		6.9	7
	(12–14)	(11–13)		(5.9–7.9)	(6.3–7.7)
t1/2 (h)b		18			10
		(16–19)			(8–12)
Vz/F (L)	2778	1587	0.57	192	119	0.62
	(2534–3044)	(1455–1731)	(0.51–0.64)	(158–231)	(107–132)	(0.53–0.73)
% dose in urine	7.8	7.8		62	68
	(6.4–9.4)	(6.6–9.3)		(53–72)	(57–80)
Clrenal (mL/min)	257	158	0.60	210	153	0.7
	(212–310)	(131–190)	(0.52–0.73)	(175–252)	(124–190)	(0.54–0.89)

^*represents median values;

^ais recovered up to 24 hour data;

^b72 is recovered up to 24 hour data.