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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).