An Open-Label, Randomized, Two-Treatment, Two Period, Two Sequence, Crossover, Multicentre, Multiple Dose, Steady State Bioequivalence study of Nevirapine Extended Release Tablet 400 mg of Apotex Inc. and Viramune® XR Extended-Release Tablet 400 mg of Boehringer Ingelheim Pty Limited., Australia in Patients Under Fasting Conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Apotex Inc
- 入组人数
- 30
- 试验地点
- 9
- 主要终点
- Cmax,ss, AUCtau, Tmax,ss, Cmin,ss, Cav,ss, Ctauss 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 Extended Release 400 mg tablets) with reference formulation (Viramune® XR Extended 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 adverse reactions associated with nevirapine are rash, fever, nausea,headache, fatigue, somnolence, vomiting, diarrhoea, abdominal pain and myalgia. Cases of anaemia and neutropenia may be associated with VIRAMUNE therapy. Arthralgia has been reported as a stand-alone event in rare instances in patients receiving VIRAMUNE containing regimens. etc., regulatory authorities are recommending that studies should be conducted on HIV-I infected patients.
Since the formaulation being studied is a extended release formaulation, a multiple dose, stady state study is being conducted as per applicable regulatory guidance. The study is being conducted on 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 30 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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects participating in the study must have: 1.Able to understand and willing to sign the informed consent form 2.Male and Non pregnant, non-lactating female subjects 18-65 years of age with documented HIV-I infection 3.BMI 18-30 kg/m2 4.Already receiving stable Nevirapine based regimen at least since 12 weeks either immediate release or extended release in combination with: a.Zidovudine and Lamivudine or b.Tenofovir and Lamivudine as separately prescribed components and to be kept constant throughout the study 5.An HIV viral load < 50 copies/mL at screening 6.A CD4+ T cell count > 50 cell/mm3 7.Willingness of study participants to comply with the all the study requirements 8.Willingness of study participants to not plan a child during the study Clinically acceptable screening laboratory values that indicate adequate baseline organ function.
排除标准
- •1.History of allergy or hypersensitivity reactions to Nevirapine or the ingredients of the formulation 2.Current treatment with an HIV protease inhibitor 3.Clinically significant cardiac, liver or kidney disease 4.Having moderate to severe renal dysfunction or serum creatinine > 3 X ULN 5.Females who are pregnant or breast feeding or planning to become pregnant or subjects not willing to take appropriate measures to prevent pregnancy during the study 6.ALT or AST ≥ 3 X ULN, Bilirubin > 2 X ULN 7.Any contraindication to use of Nevirapine 8.Past history or currently suffering from tuberculosis 9.Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion 10.Use of concomitant medication (other than the stable background antiretroviral HIV therapy) that may interfere with the pharmacokinetics of Nevirapine and/or the background antiretroviral HIV therapy 11.Consumption of grapefruit, grapefruit-like or grapefruit containing products within 7 days of drug administration.
- •12.Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication (listed in Appendix-II).
- •They can be allowed depending on Principal Investigator’s discretion in consultation with Medical monitor, if they are kept constant in the last 30 days and are expected to remain constant during the study period.
结局指标
主要结局
Cmax,ss, AUCtau, Tmax,ss, Cmin,ss, Cav,ss, Ctauss and % Fluctuation for Nevirapine
时间窗: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20 and 24 hours post | dose.
次要结局
未报告次要终点