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Pharmacokinetic Properties of 200 and 400 mg Acyclovir Tablet in Indonesia Healthy Subject
NA trial testing Acyclovir 200 MG in Drug Use in 56 participants. Completed in 28 April 2020.
| Lead sponsor | PT. Kimia Farma (Persero) Tbk |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 56 |
| Start date | 21 February 2020 |
| Primary completion | 20 April 2020 |
| Estimated completion | 28 April 2020 |
| Sites | 1 location across Indonesia |
PT. Kimia Farma (Persero) Tbk — full company profile →
Adults 18 to 55, any sex, with Drug Use. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum plasma concentration (Cmax)
| Group | Value | 95% CI |
|---|---|---|
| Acyclovir 200 mg Tablet | 613.21 | ± 244.06 |
| Zovirax® 200 mg Tablet | 675.58 | ± 258.18 |
| Acyclovir 400 mg Tablet | 807.13 | ± 278.85 |
| Zovirax® 400 mg Tablet | 882.89 | ± 351.97 |
Area Under Curve from 0 to 24 hours (AUCt)
| Group | Value | 95% CI |
|---|---|---|
| Acyclovir 200 mg Tablet | 3609.80 | ± 1425.19 |
| Zovirax® 200 mg Tablet | 3865.20 | ± 1339.05 |
| Acyclovir 400 mg Tablet | 4583.29 | ± 1518.93 |
| Zovirax® 400 mg Tablet | 5088.28 | ± 1758.74 |
The ratio between maximum concentration of test drug and reference drug after drug administration
| Group | Value | 95% CI |
|---|---|---|
| Acyclovir 200 mg Tablet | 90.65 | 82.69 – 99.37 |
| Zovirax® 200 mg Tablet | 90.65 | 82.69 – 99.37 |
| Acyclovir 400 mg Tablet | 93.63 | 84.85 – 103.33 |
| Zovirax® 400 mg Tablet | 93.63 | 84.85 – 103.33 |
The ratio between area under curve from 0 to 24 hours of test drug and reference drug
| Group | Value | 95% CI |
|---|---|---|
| Acyclovir 200 mg Tablet | 92.74 | 86.04 – 99.96 |
| Zovirax® 200 mg Tablet | 92.74 | 86.04 – 99.96 |
| Acyclovir 400 mg Tablet | 90.10 | 80.80 – 100.48 |
| Zovirax® 400 mg Tablet | 90.10 | 80.80 – 100.48 |
Time frame: before dosing (0 h) at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Acyclovir 200 mg Tablet | Zovirax® 200 mg Tablet | Acyclovir 400 mg Tablet | Zovirax® 400 mg Tablet |
|---|---|---|---|---|---|
| Headache, Dizzines | Nervous system disorders | — | — | — | — |
Data from ClinicalTrials.gov NCT04988646 adverse events section.
The objective of this present study was to asses the pharmacokinetic properties of acyclovir tablet from new product formulation (PT. Kimia Farma (Persero) Tbk) to its innovator product, Zovirax® tablet (Glaxo Wellcome S.A., Aranda, Spain)
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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