A randomized, open-label, balanced, two-treatment, two-period, two-sequence, single/multicentre, multiple dose (steady state), two-way crossover, oral bioequivalence study of Nevirapine 400 mg Prolonged-Release Tablets manufactured by Hetero Labs Limited, India and Viramune 400 mg prolonged-release tablets of Boehringer Ingelheim International GmbH, Germany in 38 adult HIV1 infected patients under fasting conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 6
- 主要终点
- AUC(0-Ï„), Cmax,ss, CÏ„,ss, tmax,ss, Cmin, ss and fluctuation for Nevirapine
研究概览
简要总结
The sponsor has developed the test formulation. This study is being conducted to compare the bioavailability and characterize the Pharmacokinetic profile of the sponsor’s formulatons (Nevirapine Prolonged Release 400 mg tablets) with reference formulation (VIRAMUNE Prolonged Release 400 mg tablets) in HIV-I Infected patients under fasting conditions, stabilized on Nevirapine based regimen either immediate release or prolonged release to assess the bioequivalence. The most serious adverse reactions associated with nevirapine are hepatitis, hepatic failure, Stevens- Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions. Hepatitis/hepatic failure may be isolated or associated with signs of hypersensitivity which may include severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis,eosinophilia, granulocytopenia, lymphadenopathy, or renal dysfunction etc., regulatory authorities are recommending that studies should be conducted on HIV-I infected patients.Since the formaulation being studied is a modified release formaulation, a multiple dose, steady state study is being conducted as per applicable regulatory guidance. The study is being conducted on HIV infected patients who are on a stable dose of Nevirapine based regimen, and the patient cannot be deprived of the Nevirapine treatment during the washout period of the study. Hence, the study has been planned to be a continuous administration of the test and reference formulation without any intervening washout period. Objective: To evaluate the pharmacokinetic bioequivalence of the test and reference products and to monitor safety of the patients. The total number of patients to enroll is around 38 from India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢HIV-I infected adult male or non-pregnant, non-lactating female patients, 18-45 years of age (both inclusive).
- •â€¢Subjects willing and able to adhere to the study assessment schedule and other protocol requirements as evidenced by a written informed consent.
- •â€¢BMI 18.5-30 kg/m2, diagnosed with documented HIV-I infection.
- •â€¢Patient who is already receiving Nevirapine 400 mg per day in combination with at least two antiretroviral drugs for at least 14 days prior to first IMP administration.
- •â€¢An HIV viral load < 50 copies/mL at screening.
- •â€¢CD4 counts >50/mm3 at screening •History of adequate renal, hepatic and cardiac function.
排除标准
- •â€¢A history of allergic or adverse reactions to Nevirapine or any comparable or similar product.
- •â€¢Current treatment with an HIV protease inhibitor.
- •â€¢Patients with moderate or severe hepatic impairment Child Pugh B or C.
- •â€¢Screening AST or ALT > 2.5 ULN.
- •â€¢History of liver function abnormalities upon re-administration of Nevirapine.
- •â€¢History or presence of cancer.
- •â€¢Use of concomitant medication (other than the stable background antiretroviral HIV therapy) that may interfere with the pharmacokinetics of Nevirapine within 14 days prior to first dosing.
- •â€¢Difficulty in swallowing solids like tablets or capsules.
- •â€¢Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery.
- •â€¢An unusual or abnormal diet, for whatever reason e.g. religious fasting.
- •â€¢Subject participating in any other clinical study or has received treatment with any investigational drug or device within 90 days prior to first dose of investigational medicinal product for the current study.
- •â€¢Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
- •â€¢History of difficulty with donating blood or difficulty in accessibility of veins.
结局指标
主要结局
AUC(0-Ï„), Cmax,ss, CÏ„,ss, tmax,ss, Cmin, ss and fluctuation for Nevirapine
时间窗: predose 0.00, 2.00, 4.00, 6.00, 8.00, 10.00, 12.00, 14.00, 15.00, 16.00, 17.00, 18.00, 19.00, 20.00, 21.00, 22.00 23.00 and 24.00 hours post dose
次要结局
- To monitor the adverse events and to ensure the safety & tolerability of the patients(NIL)