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.