Clinical trial NCT04988646: Pharmacokinetic Properties of 200 and 400 mg Acyclovir Tablet in Indonesia Healthy Subject
Official title: Pharmacokinetic Properties of Acyclovir
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Use
Keywords: bioequivalence
pharmacokinetics
Indonesian healthy subject
Acyclovir
Lead sponsor: PT. Kimia Farma (Persero) Tbk
Sponsor class: INDUSTRY
Collaborators: name: PT Pharma Metric Labs
First posted: 2021-08-03
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics Parameter
timeFrame: 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
measure: Pharmacokinetics Parameter
timeFrame: 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 outcomes:
measure: Geometric Mean Ratio
timeFrame: 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
measure: Geometric Mean Ratio
timeFrame: 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
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: PT Pharma Metric Labs
state: DKI Jakarta
Study officials:
affiliation: PT Pharma Metric Labs
name: Metta Sinta Sari Wiria
role: PRINCIPAL_INVESTIGATOR
affiliation: PT Pharma Metric Labs
name: I Gusti Putu Bagus Diana Virgo
role: STUDY_DIRECTOR
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