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Table 1 Pharmacokinetics of fosmidomycin analysed by model-independent and model-dependent approach in patients with sensitive responses in Group-I and II.

From: Assessment of the pharmacokinetics and dynamics of two combination regimens of fosmidomycin-clindamycin in patients with acute uncomplicated falciparum malaria

Pharmacokinetic Parameters

Model-independent

Model-dependent

 

Group-I

(n = 23)

Group-II

(n = 45)

Group-I

(n = 23)

Group-II

(n = 45)

tmax (hr)

2.0 (1.0–4.0)

3.0 (1.0–6.0)

2.6 (1.0–3.8)a

3.2 (0.8–4.3)

tlag (hr)

NA

NA

0.3 (0.001–0.8)

0.55 (0.001–1.6)

K01 (/hr)

NA

NA

0.35 (0.15–3.00)

0.56 (0.09–4.00)

t1/2a (hr)

NA

NA

2.0 (0.2–8.0)

1.97 (0.1–7.7)

Cmax (μg/ml)

2.41 (0.91–16.23)b

3.74(1.49–8.94)

1.77 (0.96–2.97)c

2.92 (1.40–6.93)

AUC (μg.hr/ml)

10.63 (4.27–53.85)

23.31 (11.42–66.13)

13.30 (6.89–24.33)d

26.18 (14.72–54.49)

K10 (/hr)

NA

NA

0.37 (0.09–1.92)

0.36 (0.08–2.00)

t1/2z (hr)

3.5 (0.8–14.9)e

4.2 (2.1–7.9)

NA

NA

t1/2e (hr)

NA

NA

1.6 (0.2–5.3)f

2.2 (0.3–8.2)

CL/F (l/hr)

47.51 (16.46)g

57.69 (9.29–132.54)

67.62 (23.39–130.57)

68.27 (33.03–122.31)

Vz/F (l)

272.64 (20.22–702.25)h

338.56 (131.65–895.17)

NA

NA

V/F (l)

NA

NA

194.50 (34.17–855.40)

174.11 (30.23–924.62)

Cmin-ss (μg/ml)

1.37 (1.08–5.09)i

0.80 (0.20–2.11)

1.62 (0.66–2.69)j

0.97 (0.20–2.25)

Cmax-ss (μg/ml)

2.28 (1.34–9.43)k

2.80 (1.18–6.52)

2.63 (1.46–4.64)l

3.26 (1.83–7.27)

Cave-ss (μg/ml)

1.77 (0.71–8.98)

1.94 (0.95–5.51)

2.22(1.45–4.06)

2.18(0.51–4.54)

Cmax-min-ss (μg/ml)

0.71 (0.05–4.34)m

2.03 (0.59–5.41)

1.11 (0.39–2.23)n

2.24 (0.04–5.76)

Fluctuation (%)

41.9 (40.1–203.6)°

110.0 (30.8–223.4)

49.2 (50.8–191.5)p

118.7 (41.2–218.5)

  1. Data are presented as median (95% CI).
  2. NA = Not applicable
  3. a Statistically significant difference from Group-II with p = 0.009, 95%CI = 0.9 (0.2–1.5); b p = 0.029, 95%CI = 1.45(0.77–2.04); c p < 0.0001, 95%CI = 0.78(0.15–2.11); d p < 0.0001, 95%CI = 15.99(4.15–26.77); e p = 0.022, 95%CI = 0.8(0.4–6.5),;f p < 0.0001, 95%CI = 0.2(0.09–0.9); g p = 0.006, 95%CI = 14.77(6.11–122.14); h p = 0.0001, 95%CI = 76.66(33.48–48.77); i p = 0.0001, 95%CI = 0.78(0.34–2.25); j p < 0.0001, 95%CI = 0.32(0.11–1.02); k p = 0.048, 95%CI = 0.45(0.20–0.79); l p ≤ 0.0001, 95%CI = 0.98(0.45–1.45); m p = 0.033, 95%CI = 0.64(0.23–1.78); n p = 0.039, 95%CI = 0.67(0.23–1.12); ° p = 0.001, 95%CI-65.8(23.1–102.3); p p = 0.0001, 95%CI = 62.1(24.6–123.6) (Mann-Whitney U-test)