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Table 6 Comparison of PK parameters in this study with previous published studies

From: Pharmacokinetics and bioequivalence evaluation of two oral formulations of cotrimoxazole tablets in healthy Chinese volunteers under fasting conditions

 

Source

N

Dosage

Status

Cmax (ng/mL)

Tmax (h)

T1/2 (h)

AUC0 − t (h•ng/mL)

Sulfamethoxazole

Test drug in this study

26

400 mg/80 mg

Fasting

29,500 ± 5800

2.14 ± 0.75

8.74 ± 1.15

330511.74 ± 44951.68

Reference drug in this study

26

400 mg/80 mg

Fasting

27,100 ± 5620

1.83 ± 1.01

8.80 ± 1.12

323200.10 ± 38368.41

Previous study (Baktar 2011)

10

800 mg/160 mg

Fasting

58,000 ± 6500

1.7 ± 0.7

9.4 ± 1.6

675,490 ± 100,730

Previous study (UK Public Assessment Report 2015)

-

800 mg/160 mg

Fasting

52801.2 ± 8109.56

-

-

775342.6 ± 85041.99

Trimethoprim

Test drug in this study

26

400 mg/80 mg

Fasting

894 ± 208

0.96 ± 0.53

7.17 ± 1.11

8362.34 ± 1999.94

Reference drug in this study

26

400 mg/80 mg

Fasting

863 ± 163

1.00 ± 0.65

7.18 ± 1.18

8120.30 ± 2042.16

Previous study (Baktar 2011)

10

800 mg/160 mg

Fasting

2060 ± 340

2.0 ± 1.2

8.2 ± 3.7

21,740 ± 4060

Previous study (UK Public Assessment Report 2015)

-

800 mg/160 mg

Fasting

1562.2 ± 288.64

-

-

22981.3 ± 5550.49