Bioequivalence Study of Generic GPO Saquinavir and Norvir® Versus Invirase® and Norvir® in Thai Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- To establish bioequivalence of ritonavir boosted generic GPO saquinavir generic, with Invirase® and Norvir® as reference drug.
研究概览
简要总结
The previous two studies of generic GPO saquinavir failed to prove bioequivalence. In this study the bio-equivalence will be investigated in healthy Thai volunteers, to see whether the generic GPO saquinavir shows bioequivalence when boosted with Norvir®. If the generic formulation is bioequivalent subsequent studies may follow in HIV-1 positive patients.
详细描述
The primary objective is to establish bioequivalence of "ritonavir boosted generic GPO saquinavir", with Invirase® and Norvir® as the reference drug.
The secondary objective is to evaluate the short-term tolerability and safety profiles of generic saquinavir in healthy male volunteers.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Healthy male 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
- •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
A
Day 1: receive a single dose of Invirase®/Norvir® 1,000 mg / 100mg 7-day washout period will follow. Day 8: take generic GPO squinavir/Norvir
干预措施: generic GPO saquinavir and novir vs invirase and norvir (Drug)
B
Day 1: take generic GPO squinavir/Norvir 7-day washout period will follow. Day 8: receive a single dose of Invirase®/Norvir® 1,000 mg / 100mg
干预措施: generic GPO saquinavir and novir vs invirase and norvir (Drug)
结局指标
主要结局
To establish bioequivalence of ritonavir boosted generic GPO saquinavir generic, with Invirase® and Norvir® as reference drug.
时间窗: 8 days
次要结局
- The secondary objective is to evaluate the short-term tolerability and safety profiles of generic saquinavir in healthy male volunteers.(8 days)