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

February 8, 2023 updated by: PT. Kimia Farma (Persero) Tbk

Pharmacokinetic Properties of Acyclovir

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10520
        • PT Pharma Metric Labs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • body weight within normal range (body mass index between 18 and 25 kg/m2)
  • had normal blood pressure (systolic was ranged between 90 to 120 mmHg and diastolic was ranged between 60 to 80 mmHg)
  • had normal electrocardiogram
  • absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening

Exclusion Criteria:

  • pregnant women
  • nursing mothers
  • women of childbearing potential without adequate contraception
  • had a history of contraindication or hypersensitivity to aciclovir, or other antiviral or other ingredients in the study products or a history of serious allergic reaction to any drug,
  • a significant allergic disease, or allergic reaction; presence of medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease
  • presence of any coagulation disorder or clinically significant hematology abnormalities; using any medication (prescription or non-prescription drug, food supplement, herbal medicine)
  • particularly the medication known to affect the pharmacokinetics of the study drug
  • who had participated in any clinical study within 3 months prior to the study (< 90 days)
  • subjects who had donated or lost 300 ml (or more) of blood within 3 months prior to the study
  • who were positive to HIV, HBsAg, and HCV tests
  • who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits
  • poor venous access; and who smoked more than 10 cigarettes a day
  • had a history of drug or alcohol abuse within 12 months prior to screening for this study and who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Acyclovir Tablet
Participants received Acyclovir Tablet 200 mg or 400 mg with 240 mL of water
Drug: Acyclovir 200 MG
Administered with 240 mL of water
Drug: Acyclovir 400 MG
Administered with 240 mL of water
ACTIVE_COMPARATOR: Zovirax® Tablet
Participants received Zovirax® Tablet 200 mg or 2x200 mg 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics Parameter
Time Frame: before dosing (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing
Maximum plasma concentration (Cmax)
before dosing (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing
Pharmacokinetics Parameter
Time Frame: Predose at (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours post dose
Area Under Curve from 0 to 24 hours (AUCt)
Predose at (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric Mean Ratio
Time Frame: before dosing (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing
The ratio between maximum concentration of test drug and reference drug after drug administration
before dosing (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing
Geometric Mean Ratio
Time Frame: before dosing (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing
The ratio between area under curve from 0 to 24 hours of test drug and reference drug
before dosing (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PT. Kimia Farma (Persero) Tbk

Collaborators

PT Pharma Metric Labs

Investigators

  • Principal Investigator: Metta Sinta Sari Wiria, PT Pharma Metric Labs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 21, 2020

Primary Completion (ACTUAL)

April 20, 2020

Study Completion (ACTUAL)

April 28, 2020

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 26, 2021

First Posted (ACTUAL)

August 3, 2021

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 515/STD/PML/2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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