Adverse events |
Severity1 |
Relationship to Drug2 |
Fasting Study, N=36 |
Non-fasting Study, N=343 |
Reported incidence |
Total incidence |
Reported incidence |
Total incidence |
Test
(Acyclovir) |
Reference
(Zovirax®) |
Test
(Acyclovir) |
Reference
(Zovirax®) |
Itching |
1 |
2 |
1(2.78%) |
1(2.78%) |
2 (2.78%) |
1(2.86%) |
-- |
1 (1.43%) |
Nausea |
1 |
3 |
2 (5.56%) |
3 (8.33%) |
5 (6.94%) |
2 (5.71%) |
2 (5.71%) |
4 (5.71%) |
Headache |
1 |
3 |
1(2.78%) |
2 (5.56%) |
3 (4.17%) |
-- |
1(2.86%) |
1 (1.43%) |
Dizziness |
1 |
3 |
-- |
1(2.78%) |
1(1.39%) |
1(2.86%) |
1(2.86%) |
2 (2.86%) |
Sleepiness |
1 |
3 |
-- |
1(2.78%) |
1(1.39%) |
1(2.86%) |
1(2.86%) |
2 (2.86%) |
↑ ALT |
1 |
2 |
2 (5.56%) |
1(2.78%) |
3 (4.17%) |
1(2.86%) |
2 (5.71%) |
3 (4.29%) |
↑ AST |
1 |
2 |
1(2.78%) |
2 (5.56%) |
3 (4.17%) |
2 (5.71%) |
1(2.86%) |
3 (4.29%) |
↑BP |
1 |
2 |
3 (8.33%) |
2 (5.56%) |
5 (6.94%) |
4 (11.43%) |
3 (8.57%) |
7 (10.00%) |
↓BP |
1 |
2 |
1(2.78%) |
2 (5.56%) |
3 (4.17%) |
1(2.86%) |
1(2.86%) |
2 (2.86%) |
Total |
11 (31.43%) |
15 (41.67%) |
26 (36.11%) |
13 (37.14%) |
12 (34.29%) |
25 (35.71%) |
1Severity of Adverse event: 1-Mild; 2-Moderate, 3-Severe
2Relationship to Drug: 1-Unrelated; 2-Remote; 3-Possible; 4-Probable; 5-Define
3Total 34 subjects in each test and reference formulation
Abbreviations: ↑= Increase; ↓= Decrease; ALT: Alanine transaminase; AST= Aspartate transaminase; BP= Blood Pressure
N%= Number of subjects reporting AE / number of subjects dosed with respective study drug (x 100). Total N% = Number of subjects that reported at least one AE /
number of subjects dosed with respective study drug (x 100) |
