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)
Table 4: Comparative safety and tolerability profile of acyclovir following oral administration of Test and Reference products over 24 hr under fasting and non-fasting conditions.
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