Table 2.
AEs reported following a single oral dose of the test drug (6.94 mg amlodipine besylate [5 mg as amlodipine]/50 mg losartan potassium) or the reference drug (5 mg amlodipine camsylate/50 mg losartan potassium)
| Treatment
|
P-value | ||
|---|---|---|---|
| Test drug (n=46) |
Reference drug (n=45) |
||
| Number (%) of subjects with at least one AE | 11 (23.9) | 15 (33.3) | 0.360a |
| Number of AEs | 23 | 23 | 1.000b |
| Number (%) of subjects with at least one drug-related AE | 5 (10.9) | 11 (24.4) | 0.210a |
| Number of drug-related AEs | 11 | 16 | 0.441a |
Notes:
a
Chi-square test.
b
Fisher’s exact test.
Abbreviation: AE, adverse event.