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Pharmacokinetic Properties of 200 and 400 mg Acyclovir Tablet in Indonesia Healthy Subject

NCT04988646 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-02-09

Study results available
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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)

Conditions

  • Drug Use

Interventions

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

Sponsors & Collaborators

  • PT Pharma Metric Labs

    collaborator INDUSTRY

  • PT. Kimia Farma (Persero) Tbk

    lead INDUSTRY

Principal Investigators

  • Metta Sinta Sari Wiria · PT Pharma Metric Labs

  • I Gusti Putu Bagus Diana Virgo · PT Pharma Metric Labs

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-21
Primary Completion
2020-04-20
Completion
2020-04-28

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04988646 on ClinicalTrials.gov