The Pharmacokinetics of Two Generic Co-formulations of Lopinavir/Ritonavir for HIV Infected Children: a Pilot Study of Lopimune vs. the Branded Product (SURF Study).
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Plasma concentrations of lopinavir and ritonavir.
研究概览
简要总结
This pilot pharmacokinetic study is designed to exclude a large difference (>40%) in pharmacokinetics (esp. AUC) between two new Lopimune formulations and the branded formulation. The formal bioequivalence study with adequate power will be conducted by the manufacturer. In order to get data independently from the manufacturer and to have this information in an earlier phase, this small pilot study is initiated.
The initial study showed a declined bioavailability of the granules under fasting conditions. The study has been extended with an arm determining the pharmacokinetics of the granules after food (compared to the oral solution taken with food).
详细描述
Cipla has developed two co-formulated forms of lopinavir/ritonavir for second-line antiretroviral therapy for children: Lopimune granules and Lopimune tablets. They contain 100mg lopinavir and 25mg ritonavir.
Primary objective of this study:
To determine the pharmacokinetic profile of lopinavir and ritonavir in two different co-formulations (Lopimune granules and Lopimune tablets) after single-dose in HIV-negative, healthy adult subjects, and to compare this to the branded product.
Secondary objective:
To evaluate the safety of single-dose administration of the two generic co-formulations of lopinavir/ritonavir and compare this to the branded product.
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 on the day of the first dosing.
- •Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at least 3 months prior to the first dosing.
- •Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
- •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, according to the investigator's judgment.
- •Female subject is either not of childbearing potential, or is of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or copper intrauterine device (IUD); has a vasectomized partner; or total abstinence from sexual intercourse.
排除标准
- •Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
- •Positive HIV test.
- •Positive hepatitis B or C test.
- •Therapy with any drug, including oral contraceptives.
- •Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular disorders, neurological disorders (especially seizures and migraine), gastrointestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders.
- •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.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
A
Kaletra tablets
干预措施: Lopinavir/ritonavir (Drug)
B
Lopimune granules
干预措施: Lopinavir/ritonavir (Drug)
C
Lopimune tablets
干预措施: Lopinavir/ritonavir (Drug)
结局指标
主要结局
Plasma concentrations of lopinavir and ritonavir.
时间窗: 0 (predose), 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 24 and 32 hours post ingestion (11 samples) on Days 1, 8 and 15.
次要结局
- safety: adverse events(entire study)