NCT01602055已完成1 期
A Bioequivalence Study of Two Azithromycin Tablet Formulations in Indonesian Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Plasma concentration of azithromycin until 120 h after oral administration of 500 mg Azithromycin tablet (ng/mL)
研究概览
简要总结
The aim of this study is to assess the bioequivalence of 500 mg Azithromycin FC tablets (Azivol) produced by PT. Novell Pharmaceutical Laboratories, compared to the reference product Zithromax 500 mg FC tablet produced by Pfizer Australia Pty, Ltd
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
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
- •Healthy subjects, both sexes, age between 18 to 55 years old
- •Weight with normal range according to accepted normal values for BMI (18-25 kg/m2)
- •Give a written informed consent
- •Acceptable medical history and physical examination
- •Normal hematology values including hemoglobin, hematocrit, WBC, platelets, WBC differential
- •Normal laboratory test including : Blood urea nitrogen, sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, fasting glucose, albumin and creatinine
- •Normal urinalysis results including: specific gravity, color, pH, sugar, albumin, bilirubin, RBC, WBC and casts
- •Acceptable electrocardiogram (ECG) result
- •Negative result for serological tests of Hepatitis B, Hepatitis C and HIV
- •Negative result for pregnancy test
排除标准
- •Smoker or alcoholism
- •Pregnant woman or nursing mother
- •Have history of hepatic, cardiovascular, gastrointestinal or renal disease
- •Potentially sensitive to azithromycin or other related drugs
- •Received any investigation drug within four weeks
- •Donation or loss more than 450 mL of blood within 3 months prior to the screening
研究组 & 干预措施
Azivol
Experimental
干预措施: Azithromycin (Drug)
Zithromax
Active Comparator
干预措施: Azithromycin (Drug)
结局指标
主要结局
Plasma concentration of azithromycin until 120 h after oral administration of 500 mg Azithromycin tablet (ng/mL)
时间窗: 30 days
次要结局
未报告次要终点
研究者
研究点 (1)
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