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

Not Applicable

Completed

Interventions: Drug: Acyclovir 200 MG
Drug: Zovirax 200 MG Tablet
Drug: Acyclovir 400 MG
Drug: Zovirax 400 MG Tablet

Brief 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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Acyclovir Tablet	Acyclovir 200 MG	Participants received Acyclovir Tablet 200 mg or 400 mg with 240 mL of water
Acyclovir Tablet	Acyclovir 400 MG	Participants received Acyclovir Tablet 200 mg or 400 mg with 240 mL of water
Zovirax® Tablet	Zovirax 200 MG Tablet	Participants received Zovirax® Tablet 200 mg or 2x200 mg with 240 mL of water
Zovirax® Tablet	Zovirax 400 MG Tablet	Participants received Zovirax® Tablet 200 mg or 2x200 mg with 240 mL of water

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics Parameter	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)

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Ratio	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