Trials / Completed
CompletedNCT04988646
Pharmacokinetic Properties of 200 and 400 mg Acyclovir Tablet in Indonesia Healthy Subject
Pharmacokinetic Properties of Acyclovir
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- PT. Kimia Farma (Persero) Tbk · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
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)
Detailed description
Twenty-eight healty subjects were given a single dose of acyclovir tablet or Zovirax® in dosage form 200 mg and 400mg with 240 mL of water. Then the blood samples for acyclovir was drawn and analyzed using LCMS/MS. All subjects sample plasma were analyzed for pharmacokinetic evaluation
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acyclovir 200 MG | Administered with 240 mL of water |
| DRUG | Acyclovir 400 MG | Administered with 240 mL of water |
| DRUG | Zovirax 200 MG Tablet | Administered with 240 mL of water |
| DRUG | Zovirax 400 MG Tablet | Administered with 240 mL of water |
Timeline
- Start date
- 2020-02-21
- Primary completion
- 2020-04-20
- Completion
- 2020-04-28
- First posted
- 2021-08-03
- Last updated
- 2023-02-09
- Results posted
- 2023-02-08
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT04988646. Inclusion in this directory is not an endorsement.