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. 2022 Jul 7;23:45. doi: 10.1186/s40360-022-00590-6

Table 4.

Treatment emergent adverse events (TEAEs) after a single dose of the test and reference formulations under fasting and fed conditions

AE T, fasting R, fasting T, fed R, fed
nTEAE n (%) nTEAE n (%) nTEAE n (%) nTEAE n (%)
Hypotension 26 18 (45) 21 15 (37.5) 9 7 (15.9) 7 5 (11.4)
Headache 0 0 1 1 (2.5) 0 0 0 0
Dizziness 1 1 (2.5) 1 1 (2.5) 0 0 0 0
Sinus tachycardia 1 1 (2.5) 0 0 0 0 0 0
Fever 1 1 (2.5) 1 1 (2.5) 0 0 0 0
Hypertriglyceridenmia 3 2 (5) 0 0 1 1 (2.3) 1 1 (2.3)
Leukocyturia 0 0 1 1 (2.5) 0 0 1 1 (2.3)
Blood bilirubin increased 0 0 0 0 0 0 1 1(2.3)
Creatine kinase increased 0 0 0 0 0 0 1 1 (2.3)
Hypophosphatemia 0 0 0 0 0 0 1 1 (2.3)
Atopic dermatitis 0 0 0 0 1 1 (2.3) 0 0
2nd degree Atrioventricular block 0 0 0 0 1 1 (2.3) 0 0
Anaemia 1 1 (2.5) 0 0 1 1 (2.3) 0 0