NCT00477126已完成1 期
Bioequivalence Study of Generic GPO Ritonavir Versus Norvir® in Thai Healthy Volunteers
The HIV Netherlands Australia Thailand Research Collaboration1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2007年1月最近更新:
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
- 16
- 试验地点
- 1
- 主要终点
- Establish bioequivalence of generic GPO ritonavir, with Norvir® as the reference drug.
研究概览
简要总结
To establish bioequivalence of ritonavir generic capsule, with Norvir® as reference drug.
详细描述
This study will be performed to evaluate if the new generic GPO ritonavir product is bio-equivalent to Norvir and to compare the short-term tolerability and safety profiles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Healthy male or female 18-45 years old
- •Documented negative test for HIV-1 infection < 1 wk prior to start of study and with no risk of
- •HIV exposure in the last 6 months
- •For female subjects: documented negative pregnancy test <3 wk prior to start of study, not breastfeeding
- •BMI 18-25
- •Normal physical examination
- •Normal CBC, BUN, Cr, AST, ALT, Total bilirubin, no evidence of active or chronic HBV or HCV Infection
排除标准
- •History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the study.
- •Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- •Inability to understand the nature and extent of the study and the procedures required.
- •Participation in a drug study within 60 days prior to the first dose.
- •Febrile illness within 3 days before the first dose.
- •Use of concomitant medication
- •Smoke cigarettes not more than 10 cigarettes a day.
- •Drink alcohol not more than 2 units a day
- •Discontinue smoking and alcohol for at least 1 month before enrollment.
- •Take other medication regularly
- •Involvement in any drug addiction
- •Heart disease, hypertension, liver disease, kidney disease, GI disease, allergic disease or other diseases which may interfere with the PK of study drugs
研究组 & 干预措施
1
Active Comparator
start generic product cross over to reference product
干预措施: GPO ritonavir versus Norvir (Drug)
2
Active Comparator
start reference product cross over to generic product
干预措施: GPO ritonavir versus Norvir (Drug)
结局指标
主要结局
Establish bioequivalence of generic GPO ritonavir, with Norvir® as the reference drug.
时间窗: 2 months
次要结局
- Evaluate the short-term tolerability and safety profiles of generic ritonavir in healthy male and female volunteers.(2 months)
研究者
研究点 (1)
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