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. 2023 Aug 1;14:1226014. doi: 10.3389/fphar.2023.1226014

TABLE 2.

Summary of treatment-emergent adverse events.

Single dose Multiple-dose Total
1.5 mg (N = 12) 2.5 mg a (N = 12) 5 mg (N = 12) 2.5 mg (N = 12) N = 49
Number of subjects (percent)
Any AEs 2 (16.7) 7 (58.3) 8 (66.7) 8 (61.5) 25 (51.0)
Dizziness 0 (0) 0 (0) 4 (33.3) 0 (0) 4 (8.2)
hyperuricemia 0 (0) 1 (8.3) 2 (16.7) 0 (0) 3 (6.1)
Upper respiratory tract infection 0 (0) 1 (8.3) 0 (0) 2 (15.4) 3 (6.1)
Myalgia 0 (0) 0 (0) 0 (0) 1 (7.7) 1 (2.0)
Nasal obstruction 0 (0) 0 (0) 0 (0) 1 (7.7) 1 (2.0)
Sinus tachycardia 0 (0) 0 (0) 0 (0) 1 (7.7) 1 (2.0)
Ocular hypertension 0 (0) 1 (8.3) 0 (0) 0 (0) 1 (2.0)
DBP decreased 0 (0) 0 (0) 1 (8.3) 2 (15.4) 3 (6.1)
ECG PR shortened 0 (0) 1 (8.3) 0 (0) 0 (0) 1 (2.0)
ECG T wave abnormal 0 (0) 0 (0) 0 (0) 1 (7.7) 1 (2.0)
Heart rate decreased 0 (0) 0 (0) 0 (0) 1 (7.7) 1 (2.0)
Heart rate increased 1 (8.3) 1 (8.3) 0 (0) 0 (0) 2 (4.1)
Blood bilirubin increased 1 (8.3) 0 (0) 0 (0) 0 (0) 1 (2.0)
Blood TG increased 0 (0) 0 (0) 2 (16.7) 1 (7.7) 3 (6.1)
CRE increased 0 (0) 2 (16.7) 0 (0) 0 (0) 2 (4.1)
ALT increased 0 (0) 1 (8.3) 0 (0) 0 (0) 1 (2.0)
RBC urine positive 0 (0) 1 (8.3) 2 (16.7) 0 (0) 3 (6.1)
WBC urine positive 0 (0) 1 (8.3) 1 (8.3) 0 (0) 2 (4.1)
MC count increased 0 (0) 0 (0) 0 (0) 1 (7.7) 1 (2.0)
Urinary sediment present 0 (0) 1 (8.3) 0 (0) 0 (0) 1 (2.0)
Protein urine present 0 (0) 0 (0) 1 (8.3) 0 (0) 1 (2.0)

DBP: diastolic blood pressure; ECG: electrocardiogram; TG: triglycerides; CRE: serum creatinine; ALT: alanine aminotransferase; RBC: red blood cells; WBC: white blood cells; MC: mononuclear cell.

a

AEs, were counted for both fasted and fed phase after the single dose administration of dimdazenil.