Study No.*

Treatment

Pseudoephedrine

Acetylsalicylic acid

Salicylic acid

Cmax (µg/L)

AUC0-∞

(µg × h/L)

Tmax (hours)

Cmax (µg/mL)

AUC0-∞

(µg × h/mL)

Tmax (hours)

Cmax (µg/mL)

AUC0-∞

(µg × h/mL)

Tmax (hours)

IMP 14892

Aspirin Complex compared to experimental product

147/21.6 (92.7 - 230)

1110/27.4 (666 - 2215)

0.83 (0.33 - 4.00)

13.00/22.3

(8.9 - 24.5)

7.87/18.4

(5.5 - 11.3)

0.31

(0.17 - 0.53)

24.30/15.6

(17.9 - 31.4)

111.0/29.0

(72.5 - 209)

0.83

(0.33-2.00)

IMP 15776

Aspirin Complex

Hot Drink

154/29.6

(90.3 - 291)

921/24.2 (625 - 1886)

0.83

(0.25 - 3.0)

15.86/35.1

(8.1 - 30.5)

8.94/15.5

(6.7 - 11.7)

0.25

(0.15 - 0.50)

27.75/17.9

(18.1 - 37.6)

155.5/32.5

(92.4 - 326)

0.67

(0.25-1.50)

IMP 15776

Aspirin Complex

143/29.6

(85.8 - 257)

952/26.1

(648 - 2035)

0.83

(0.33 - 3.0)

14.97/33.3

(5.4 - 24.6)

9.17/15.0

(7.0 - 12.6)

0.25

(0.17 - 0.67)

27.08/15.0

(19.7 - 36.7)

152.4/31.8 (96.8 - 331)

0.91

(0.33-2.00)

IMP 11757

Aspirin Complex compared to experimental product

122/24.7 (78.3 - 196.7)

966/26.2

(611 - 1678)

0.83

(0.33 - 3.0)

12.57/34.0

(7.0 - 29.5)

6.34/20.1

(4.7 - 9.7)

0.25

(0.17 - 0.35)

31.32/21.7

(21.1 - 43.5)

133.8/22.8

(85.2 - 192)

0.83

(0.42-2.00)

Summary**

141/1.1

(122-154)

985/1.1

(921 - 1110)

0.83

(0.83 - 0.83)

14.03/1.1

(12.57 - 15.86)

8.00/1.2

(6.34 - 9.17)

0.26

(0.25 - 0.31

27.50/1.1

(24.30 - 31.32)

137/1.1

(111.0 - 155.5)

0.81

(0.67 - 0.91)