Safety assessment
No protocol violations or serious adverse events were identified in this study. The safety profile of both the test and reference formulations was good during the conduct of the trial. A total of 50 adverse events were collected from 28 subjects in the fasting trial. These adverse events included: dizziness (n=8), headache (n=6), low back pain (n=3), inflammation of the left lower lung (n=1), positive urine red blood cells (n=6), hypotension (n=1), elevated myoglobin (n=1), elevated creatine kinase (n=1), anemia (n=2), finger burns (n=1), skin lesions on the right finger (n=1), intraventricular block (n=1), and upper respiratory tract infection (n=4), cough (n=1), skin trauma (n=1), elevated triglycerides (n=2), tachycardia (n=2), elevated cholesterol (n=1), abdominal pain (n=1), elevated blood uric acid (n=1), gastric distention (n=1), chest tightness (n=1), nosebleeds (n=1), nausea (n=1), and vomiting (n=1). None of the AEs were serious adverse events. In addition, no clinically significant changes were found in other safety assessments, including physical examination, electrocardiogram, or laboratory tests.
In the postprandial trial, one adverse event was collected in one subject before dosing and 58 subadverse events occurred in 29 subjects after dosing. These adverse events included: dizziness (n=9), headache (n=3), tachycardia (n=7), prolonged ECG P-R interval (n=2), elevated triglycerides (n=12), elevated uric acid (n=1), altered ECG T waves (n=1), gingival pain (n=2), stomach pain (n=1), decreased white blood cell count (n=1), anemia (n=1), abdominal pain (n=1), hypotension (n=10), decreased platelets (n=1), positive urine red blood cells (n=3), nasal congestion (n=1), dry throat (n=1), and skin abrasions (n=1). No serious adverse events occurred. No clinically significant changes were found in other safety assessments, including physical examination, electrocardiogram, or laboratory tests.