. 2014 Dec 18;10:15–23. doi: 10.2147/COPD.S68094

Table 2.

Plasma PK parameters

Parameter	Group	N	n	n*	Geometric means	95% CI	CVb (%)
(A)
UMEC 125 μg
AUC_(0–0.25h) (h.pg/mL)	Healthy	9	9	0	20.3	13.8–29.7	53.0
AUC_(0–0.25h) (h.pg/mL)	Severe renal impairment	9	9	0	18.9	13.1–27.4	51.0
AUC_(0–2h) (h.pg/mL)	Healthy	9	9	1	56.6	34.8–91.6	69.7
AUC_(0–2h) (h.pg/mL)	Severe renal impairment	9	9	0	59.1	40.5–86.3	52.3
C_max (pg/mL)	Healthy	9	9	0	127.6	84.8–191.9	57.1
C_max (pg/mL)	Severe renal impairment	9	9	0	113.2	75.2–170.4	57.3
t_last (h)^a	Healthy	9	9	0	2.00	0.25–4.00	NA
t_last (h)^a	Severe renal impairment	9	9	0	2.00	0.50–4.00	NA
t_max (h)^a	Healthy	9	9	0	0.08	0.08–0.12	NA
t_max (h)^a	Severe renal impairment	9	9	0	0.08	0.08–0.12	NA
UMEC/VI 125/25 μg
AUC_(0–0.25h) (h.pg/mL)	Healthy	9	9	0	23.4	16.1–34.2	52.2
AUC_(0–0.25h) (h.pg/mL)	Severe renal impairment	9	9	0	23.6	17.1–32.6	44.2
AUC_(0–2h) (h.pg/mL)	Healthy	9	9	0	60.4	44.6–81.9	41.1
AUC_(0–2h) (h.pg/mL)	Severe renal impairment	9	9	0	66.3	48.8–90.1	41.5
C_max (pg/mL)	Healthy	9	9	0	152.4	101.1–229.7	57.4
C_max (pg/mL)	Severe renal impairment	9	9	0	149.2	104.2–213.5	49.3
t_last (h)^a	Healthy	9	9	0	2.0	0.50–4.02	NA
t_last (h)^a	Severe renal impairment	9	9	0	2.0	0.50–4.00	NA
t_max (h)^a	Healthy	9	9	0	0.08	0.08–0.12	NA
t_max (h)^a	Severe renal impairment	9	9	0	0.08	0.08–0.12	NA
Parameter	Treatment	Group comparison	Adjusted geometric means	Ratio	90% CI

(B)
AUC_(0–2h) (h.pg/mL)	UMEC 125 μg	Severe renal impairment/healthy	59.1/65.8	0.90	0.64–1.26
AUC_(0–2h) (h.pg/mL)	UMEC/VI 125/25 μg	Severe renal impairment/healthy	66.3/60.4	1.10	0.79–1.52
C_max (pg/mL)	UMEC 125 μg	Severe renal impairment/healthy	113.2/127.6	0.89	0.58–1.35
C_max (pg/mL)	UMEC/VI 125/25 μg	Severe renal impairment/healthy	149.2/152.4	0.98	0.64–1.49

Notes: (A) Summary Statistics for umeclidinium parameters.

Presented as median and range, instead of geometric mean and 95% CI, respectively. (B) Statistical analysis of umeclidinium parameters. Values of UMEC AUC_(0–2h) that were non-calculable due to nonquantifiable values were not imputed for the statistical analysis but were imputed for raw summary statistics.

Abbreviations: AUC, area under the curve; CI, confidence interval; C_max, maximum observed plasma concentration; CVb, between-subject coefficient of variation; n*, number imputed; NA, not applicable; PK, pharmacokinetic; t_last, time to last quantifiable concentration; t_max, time to C_max; UMEC, umeclidinium; VI, vilanterol; N, number of patients included in the study population; n, number of patients included in the assessment.