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 |