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Table 1 Subject demographics and baseline characteristics

From: Evaluation of two novel tablet formulations of artemether-lumefantrine (Coartem®) for bioequivalence in a randomized, open-label, two-period study

  

80/480 mg and four standard tablets

60/360 mg and three standard tablets

Sequence

Sequence

1a

2a

Total

1b

2b

Total

N = 30

N = 30

N = 60

N = 30

N = 30

N = 60

Age (years)

Mean (SD)

39.9 (9.37)

39.8 (8.75)

39.9 (8.99)

41.2 (9.86)

40.5 (9.27)

40.8 (9.50)

 

Range

19-53

23-53

19-53

20-53

24-53

20-53

Height (cm)

Mean (SD)

165.0 (6.45)

165.8 (4.78)

165.4 (5.64)

164.8 (6.17)

164.5 (6.16)

164.6 (6.11)

 

Range

152-184

153-178

152-184

151-177

154-176

151-177

Weight (kg)

Mean (SD)

65.78 (10.64)

63.34 (8.97)

64.56 (9.83)

63.24 (10.44)

61.67 (9.68)

62.46 (10.02)

 

Range

50.4-94.8

50.2-81.4

50.2-94.8

50.2-84.4

50.4-83.1

50.2-84.4

BMI (kg/m2)

Mean (SD)

24.12 (3.14)

23.06 (3.19)

23.59 (3.18)

23.25 (3.26)

22.73 (2.85)

22.99 (3.05)

 

Range

18.74-29.41

18.22-28.95

18.22-29.41

18.68-29.73

18.68-29.73

18.68-29.73

Sex

Male

30 (100%)

30 (100%)

60 (100%)

30 (100%)

30 (100%)

60 (100%)

Race

Asian

30 (100%)

30 (100%)

60 (100%)

30 (100%)

30 (100%)

60 (100%)

Ethnicity

Indian (Indian subcontinent)

30 (100%)

30 (100%)

60 (100%)

30 (100%)

30 (100%)

60 (100%)

  1. Sequence 1a: single dose of 80/480 mg AL tablet (80 mg artemether/480 mg lumefantrine) // single dose of four tablets of AL (each 20 mg artemether/120 mg lumefantrine).
  2. Sequence 2a: single dose of four tablets of AL (each 20 mg artemether/120 mg lumefantrine) // single dose of 80/480 mg AL tablet (80 mg artemether/480 mg lumefantrine).
  3. Sequence 1b: single dose of 60/360 mg AL tablet (60 mg artemether/360 mg lumefantrine) // single dose of three tablets of AL (each 20 mg artemether/120 mg lumefantrine).
  4. Sequence 2b: single dose of three tablets of AL (each 20 mg artemether/120 mg lumefantrine) // single dose of 60/360 mg AL tablet (60 mg artemether/360 mg lumefantrine).