Pharmacokinetic Properties of Acyclovir
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Pharmacokinetics Parameter
研究概览
简要总结
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)
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Acyclovir Tablet
Participants received Acyclovir Tablet 200 mg or 400 mg with 240 mL of water
干预措施: Acyclovir 200 MG (Drug)
Acyclovir Tablet
Participants received Acyclovir Tablet 200 mg or 400 mg with 240 mL of water
干预措施: Acyclovir 400 MG (Drug)
Zovirax® Tablet
Participants received Zovirax® Tablet 200 mg or 2x200 mg with 240 mL of water
干预措施: Zovirax 200 MG Tablet (Drug)
Zovirax® Tablet
Participants received Zovirax® Tablet 200 mg or 2x200 mg with 240 mL of water
干预措施: Zovirax 400 MG Tablet (Drug)
结局指标
主要结局
Pharmacokinetics Parameter
时间窗: 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)
次要结局
- 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)