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

Kimia Farma

Status

Completed

Conditions

Drug Use

Treatments

Drug: Zovirax 200 MG Tablet

Drug: Zovirax 400 MG Tablet

Drug: Acyclovir 400 MG

Drug: Acyclovir 200 MG

Study type

Interventional

Funder types

Industry

Identifiers

NCT04988646

515/STD/PML/2019

Details and patient eligibility

About

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)

Full 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

Enrollment

56 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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