The Influence of Raltegravir on Pravastatin Pharmacokinetics in Healthy Volunteers (GRAPPA)
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 concentrations of pravastatin and raltegravir.
研究概览
简要总结
The purpose of this trial is to determine the effect of raltegravir on pravastatin pharmacokinetics and vice versa by intrasubject comparison.
详细描述
Pravastatin is a first choice statin for HIV-infected patients. Therefore, raltegravir and pravastatin are expected to be co-administered frequently in HIV-infected patients.Since both agents share the same metabolic pathway, there is a potential for a pharmacokinetic drug-drug interaction.
Because co-administration will be indicated in many HIV-infected patients, it is essential to investigate this potential interaction.
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
- 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
- •Subject is at least 18 and not older than 55 years of age.
- •Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day.
- •Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m
- •Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
- •Subject is in good age-appropriate health condition.
- •Subject has a normal blood pressure and pulse rate.
排除标准
- •Documented history of sensitivity/idiosyncrasy to medicinal products or exci-pients.
- •Positive HIV test.
- •Positive hepatitis B or C test.
- •Pregnant female or breast-feeding female.
- •Therapy with any drug.
- •Relevant history or presence of pulmonary disorders (especially COPD), car-diovascular disorders, neurological disorders (especially seizures and mi-graine), gastro-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders.
- •Fasting triglyceride levels > 8.0 mmol/L
- •Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- •History of or current abuse of drugs, alcohol or solvents.
- •Inability to understand the nature and extent of the trial and the procedures required.
- •Participation in a drug trial within 60 days prior to the first dose.
- •Donation of blood within 60 days prior to the first dose.
- •Febrile illness within 3 days before the first dose
研究组 & 干预措施
A
Pravastatin 40 mg QD for 4 days
干预措施: Pravastatin (Drug)
B
Raltegravir 400mg BD for 4 days
干预措施: Raltegravir (Drug)
C
Interaction between pravastatin and raltegravir
干预措施: Pravastatin and raltegravir (Drug)
结局指标
主要结局
Plasma concentrations of pravastatin and raltegravir.
时间窗: t=0 (predose), 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and (24: for pravastatin only) hours post ingestion on Days 4, 18 and 32. Trough level on Day 2, 16 and 30.
次要结局
- To investigate the non-steady state changes in serum low density lipoprotein (LDL) cholesterol secondary to pravastatin use in the presence or absence of raltegravir(Screening and Days 1, 5, 15, 19, 29 and 33.)
- To evaluate the safety of combined use of pravastatin and raltegravir(entire trial)
- Determination of pharmacokinetic parameters(at each sampling time)