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

• Status: Completed
• Trial end date: 2020-04-28
• Target enrollment: 0
• Participant gender: All

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)

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PT. Kimia Farma (Persero) Tbk
• Collaborator: PT Pharma Metric Labs
• Treatments: Acyclovir

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