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

Study Overview
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Brief Summary
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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
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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

Official Title
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Pharmacokinetic Properties of Acyclovir

Conditions
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Drug Use

Intervention / Treatment
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* Drug: Acyclovir 200 MG
* Drug: Acyclovir 400 MG
* Drug: Zovirax 200 MG Tablet
* Drug: Zovirax 400 MG Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, single blind, single dose, 2-periods, cross-over design study with one week washout period between each treatment in 28 healthy subjects under fasting condition
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acyclovir Tablet<br>Participants received Acyclovir Tablet 200 mg or 400 mg with 240 mL of water | Drug: Acyclovir 200 MG<br>* Administered with 240 mL of water<br>Drug: Acyclovir 400 MG<br>* Administered with 240 mL of water<br>|
| Active Comparator: Zovirax® Tablet<br>Participants received Zovirax® Tablet 200 mg or 2x200 mg with 240 mL of water | Drug: Zovirax 200 MG Tablet<br>* Administered with 240 mL of water<br>Drug: Zovirax 400 MG Tablet<br>* Administered with 240 mL of water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics Parameter | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioequivalence, pharmacokinetics, Indonesian healthy subject, Acyclovir