CTRI/2021/04/033064已完成未知
An open label, balanced, randomized, two-treatment, two-sequence, two-period, cross-over, single-dose, oral bioequivalence study of Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension 60mg/5mg/30mg (1 Ã? 5 Tablets) (Test) of Aurobindo Pharma Limited, India with Dolutegravir (GSK1349572)/Abacavir/Lamivudine Dispersible Tablets 5 mg/60 mg/30 mg (1 Ã? 5 Tablets) (Reference) of ViiV Healthcare, UK in 14 healthy, adult, human subjects under fed conditions.
APL Research Centre Aurobindo Pharma Limited0 个研究点目标入组 14 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 14
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.Healthy, adult, human subjects within the age range of 18 to 45 years (inclusive of both)
- •2.A body mass index within the range of 18.50-29.99 Kg/m2 (inclusive of both)
- •3.Participation is truly voluntarily
- •4.Given written informed consent to participate in the study
- •5.Absence of disease markers of HIV 1 and 2, hepatitis B and C virus and RPR
- •6.Absence of significant diseases and abnormalities in medical history, systemic and physical examination during the screening
- •7.Absence of clinically significant abnormal laboratory values on laboratory evaluation (any laboratory values which are beyond the normal ranges, have been evaluated with appropriate justification by the investigator/ physician) during screening (refer Appendix-V)
- •8.A normal 12-lead ECG
- •9.Normal values in the assessment of depression using depression scale (refer Appendix-XV) during check-in of each period
- •10.Normal values of Creatinine clearance (CrCl) test during period-I check-in
- •11.Normal levels of serum amylase test, serum creatine phosphokinase (CPK) test and serum triglycerides test during check-in of period-I
- •12.The subject is negative for the HLA-B X 5701 allele test
- •13.A normal chest X-ray (PA view) (done within past 06 months)
- •14.Compliance with requirement of the entire protocol
- •15.Individuals of childbearing potential may be eligible to enter and participate in the study if they are of non-childbearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and equal to or older than 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy
- •16.Male subject should be agreed to use an approved form of birth control from period-I dosing till 01 month after the last dose of the study medication as a birth control restriction. Approved birth control methods (barrier forms) during this period are:
- •a.Male latex condom with or without spermicide
- •b.Condom with diaphragm
- •c.Have undergone vasectomy (vasectomy must have been done more than 06 months prior to first dosing)
- •17.Subjects who are able to read the medication guide (Appendix-XIII) and Informed Consent Document
排除标准
- •2.History or evidence of known hypersensitivity to Dolutegravir, Abacavir and Lamivudine or any component of the formulations
- •3.History or evidence of moderate to severe renal impairment or moderate to severe hepatic impairment
- •4.History or evidence of depression, suicidal ideation or behaviour
- •6.ytomegalovirus, pneumocystis jirovecii pneumonia or tuberculosis, Graves disease and polymyositis
- •7.History or evidence of unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypo-albuminemia, esophageal or gastric varices or persistent jaundice), cirrhosis, known biliary abnormalities (apart from hyperbilirubinemia or jaundice due to Gilberts syndrome or asymptomatic gallstones)
- •8.History or evidence of myocardial infarction
- •9.History or evidence of lactic acidosis and severe hepatomegaly with steatosis
- •10.History or evidence of pancreatitis
- •11.History or evidence of ALT greater than 1.5 ULN and or total bilirubin ALT greater than 1.5 at baseline
- •12.History or evidence of concomitant use of Dofetilide (or pilsicainide), Etravirine, Trimethoprim, Efavirenz, Nevirapine, Fosamprenavir/ ritonavir and Tipranavir/ ritonavir, Dalfampridine, Carbamazepine, Oxcarbazepine, Phenytoin, Phenobarbital, St. Johns wort (Hypericum perforatum), medications containing polyvalent cations (example: Mg or Al): Cation-containing antacids or laxatives, Sucralfate buffered medications, oral calcium and iron supplements, including multivitamins containing calcium or iron, Metformin, Rifampin, Methadone and Sorbitol
- •13.Blood pressure: Systolic greater than 140 mm Hg and less than 110 mm Hg, Diastolic less than 70 mm Hg and greater than 90 mm Hg
- •14.History of significant systemic diseases, seizures, psychiatric disorders, neurological disorders, metabolic disorders, nutritional disorders and/or allergic rash
- •15.Family history of neurological disorder
- •16.Habit of consuming high caffeine (more than 5 cups of coffee or tea per day) or tobacco (more than 9 cigarettes/ beedies/ cigars per day)
- •17.History of alcohol consumption for more than two units/day (1 unit equals to 30 mL of spirit or 1 pint of beer)
- •18.History of difficulty with donating blood or difficulty in accessibility of veins
- •19.Donation of blood (one unit or 350 mL) within 90 days prior to study check-in
- •20.History of addiction to any recreational drug or drug dependence
- •21.Participation in any clinical study within the past 90 days
- •22.An unusual or abnormal diet, for whatever reason for at least 48.00 hours prior to check-in of each period, example: fasting due to religious reasons
- •23.Use of any prescription drugs or over-the-counter drugs (example: cold preparations, antacid preparations, vitamins or natural products etc.) within 14 days prior to check-in of period-I and unwilling to refrain from the same till the entire duration of the study
- •24.Consumed food or beverages containing alcohol or xanthine products (chocolate, tea, coffee, cola or energy drinks), cigarettes or tobacco products for at least 48.00 hours prior to check-in of each period
- •25.Consumed grapefruit or grapefruit like citrus fruits (mosambi/ sweet lime) or juice for at least 48.00 hours prior to check-in of each period
- •26.History of dehydration from diarrhea, vomiting or any other reason for at least a period of 24.00 hours prior to check-in
研究者
相似试验
尚未招募
1 期
Bioequivalence study of Bortezomib 3.5 mg powder for solution for Injection and VELCADE 3.5 mg powder for solution for injection in Relapsed/Refractory Multiple Myeloma patients under fasting conditionsCTRI/2013/12/004202Dr Reddys Laboratories Limited84
已完成
不适用
Bioequivalence study on Bilastine 10 mg and Montelukast 4 mg per 5ml oral suspensioCTRI/2022/12/048342RIVPRA FORMULATION PVT LTD23
已完成
不适用
Bioequivalence study of Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension 60mg/5mg/30mg (1 Ã? 5 Tablets) with comparision to the marketed product under fasting conditions.CTRI/2021/04/033077APL Research Centre Aurobindo Pharma Limited14
尚未招募
1 期
study comparing test product Bilastine 3.3mg plus Dextromethorphan Hydrobromide 10mg plus Phenylephrine Hydrochloride 5mg per 5mL with reference product BilazestTM Kids (Bilastine Oral Solution 2.5mg per mL) in healthy adult human subjects under fed conditioCTRI/2023/12/060423Synokem Pharmaceuticals Ltd
进行中（未招募）
Unknown
Bioequivalence study of Metformin prolonged release tablets 1000 mg in comparison with Glucophage®1000 mg XR tablets (Metformin Hydrochloride prolonged release tablets) of in healthy, adult, human subjects under fed conditionsCTRI/2023/04/051403Pinnacle Life Science Pvt. Ltd.