CTRI/2018/01/011185招募中未知
An open label, randomized, single centre two-treatment, two-sequence, two-period, crossover, multiple dose comparative oral bioavailability study of Nevirapine Prolonged Release Tablets 400 mg (Test) of Aurobindo Pharma Ltd., India and Viramune (Nevirapine) 400 mg Prolonged-Release Tablets (Reference) of Boehringer Ingelheim Pharma GmbH & Co.KG, Germany in 36 HIV-1 Infected Patients under fasting conditions.
APL Research Center0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1.Male or female subject aged between 18 and 65 years of age (both inclusive) at the time of informed consent and should have BMI >= 18.5 to <= 30 kg/m2.
- •2.Non smokers and non alcoholics.
- •3.Subject with a stable Nevirapine based combination antiretroviral regimen for at least the preceding 12 weeks (or 6 weeks if switched from an antiretroviral regimen containing two nucleoside analogues and Efavirenz) that is recommended according to British HIVAssociation clinical guidelines:
- •a. Abacavir and lamivudine {ABC/3TC} as fixed dose combination
- •b. Tenofovir and emtricitabine {TDF/FTC}
- •c. Zidovudine and lamivudine {AZT/3TC}, OR
- •d. Tenofovir and lamivudine as separately prescribed components and kept constant (in combination and dosage) throughout the whole course of the study.
- •4.Absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, psychiatric, gastrointestinal, renal, hepatic, obstructive disorders, cholestasis, and metabolic disease.
- •5.Subjects with An HIV viral load < 50 copies/mL in preceding 12 months and at screening.
- •6.Subjects with a CD4+ Tcell count > 50 cell/mm3 in preceding 12 months and at screening.
- •7.Subject should be otherwise healthy as determined by general and systemic examination, medical history and have no significant abnormality in any of the laboratory parameters including ECG and Chest X-ray.
- •8.Subject with no history of addiction to any recreational drug or drug dependence
- •9.Acceptable screening laboratory values that indicate adequate baseline organ function.
- •10.Willingness to abstain from ingesting medications that are listed as contraindicated for Nevirapine during the whole course of the study.
- •11.Capable of completing patient diaries.
- •12.Capable and willing to come back for PK assessments and follow up.
- •13.Willingness to refrain from excessive physical activity during the trial.
- •14.Subject must be able to adhere to the study visit schedule and other protocol requirements and must have given informed consent prior to any screening procedures.
- •15.Female subject of childbearing potential should be willing to use a reliable method of birth control
- •16.Female subject must have a negative pregnancy test at Screening.
排除标准
- •1.Subject Current treatment with an HIV protease inhibitor
- •2.Subject had Infection with HIV2 or HIV1 group O.
- •3.Subject Laboratory parameters > DAIDS grade 2 Coagulation.
- •4.Subject Laboratory parameters > DAIDS grade 2 Total triglycerides
- •5.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)
- •6.Intake of products containing St. Johns Wort from 14 days before treatment with study medication (Day 1) and not willing to abstain from it throughout the study until completion of the study
- •7.Subject undergone major surgery within 4 weeks of enrolment.
- •8.Subject had history of hypersensitivity or idiosyncratic reactions to any drug product or its excipients etc
- •9.History of difficulty with donating blood or difficulty in swallowing the drug or difficulty in accessibility of veins.
- •10.High caffeine (more than 5 cups of coffee or tea/day) consumption.
- •11.Subject diagnosed to be Hepatitis B (HBs Ag) or Hepatitis C (HCV) virus reactive/positive.
- •12.Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
- •13.Female subject who is pregnant or currently breast-feeding.
- •14.Subject donated blood >= 350 mL within 90 days of screening.
- •15.Subject participation in another clinical trial within the preceding 90 days of study starts.
- •16.Received pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study
- •17.Subject with history of arterial thrombosis or deep vein thrombosis within the past year.
- •18.Patients on Tuberculosis treatment with Rifampicin
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