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Table 4 Treatment emergent adverse events (TEAEs) after a single dose of the test and reference formulations under fasting and fed conditions

From: Bioequivalence evaluation and food effect assessment of Lisinopril/amlodipine tablets in healthy Chinese subjects 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