CTRI/2020/06/025583尚未招募未知
Single dose Fasting In-Vivo Bioequivalence study of Dolutegravir Sodium Dispersible Tablet 10 mg(Macleods Pharmaceuticals Ltd., India) with two tablets of Dolutegravir 5mg dispersible tabletsmanufactured by GlaxoSmithKline, UK on behalf of ViiV Healthcare, UK in healthy, adult, human malesubjects.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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 human male volunteers within the age range of 18 to 45 years.
- •2. Presently non-tobacco users (smokers and chewers).
- •3. Willingness to provide written informed consent to participate in the study.
- •4. Body-mass index (BMI) between 18.50 kg/m2 and 29.99 kg/m2 (both inclusive) with body weight not
- •less than 50 kg.
- •5. Absence of significant disease or abnormal laboratory values or laboratory evaluation, medical
- •history or physical examination during the screening.
- •6. Have a normal 12-lead ECG or one with abnormality considered to be clinically insignificant.
- •7. Have a normal chest X-ray PA view or one with abnormality considered to be clinically insignificant.
- •8. Comprehension of the nature and purpose of the study and compliance with the requirement of the
- •distributed ICF.
排除标准
- •1. Personal history of allergy or hypersensitivity to Dolutegravir or allied drugs or excipients (D-Mannitol,Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Silicified Microcrystalline Cellulose,Crospovidone, Calcium Sulfate Dihydrate, Sucralose, Strawberry Cream Flavour, Sodium Stearyl Fumarate, White film coat (Contains: Hypromellose, Polyethylene Glycol and Titanium Dioxide)].
- •2. Any major illness in the past 90 days or any clinically significant ongoing chronic medical illness e.g.Congestive Cardiac Failure, Hepatitis, Hypotensive episodes, Hyperglycemia etc.
- •3. Presence of any abnormal laboratory values during screening e.g. abnormality of liver function test,renal function test etc.
- •3.1 Alanine transaminase (ALT) >1.5x upper limit of normal (ULN)
- •3.2 Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- •3.3 Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones)
- •4. Severe cardiac, renal or liver impairment, gastro-intestinal disease or other conditions, any other organ or system impairment.
- •5. History of seizures, epilepsy or any kind of Neurological disorders.
- •6. Past history of Anaphylaxis or Angioedema.
- •7. Presence of disease markers of HIV or Hepatitis B or Hepatitis C virus.
- •8. History of chronic consumption of any kind of alcoholic beverages for more than 2 years or having consumed alcohol within 48 hours prior to dosing.
- •9. Consumption of products containing xanthine derivatives (chocolates, tea, coffee or cola drinks) or tobacco products within 48 hours prior to dosing.
- •10. Consumption of grapefruit or grapefruit containing products or any cruciferous vegetables (eg.broccoli, brussels sprouts, etc.) or char-broiled meat prior 7 days of investigational product administration.
- •11 . Use of any recreational drug or a history of drug addiction.
- •12. Participation in any clinical trial within the past 90 days.
- •13. History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm.
- •14. Donation of blood (one unit or 350 ml) within 90 days prior to receiving the first dose of study
- •medication.
- •15. Consumption of any other prescription drug or over the counter (OTC) drugs (including vitamins and
- •medicinal products from natural origin) within two weeks prior to receiving the first dose of study
- •medication or repeated use of drugs within the last four weeks and throughout subjects participation in the study.
- •16. Consumption of products (medicines or supplements) containing Ca/Fe/Mg within 48 hours prior to dosing.
- •17. An unusual diet for whatever reason e.g. low sodium diet, for two weeks prior to receiving any
- •medication and throughout subjects participation in the study.
- •18. Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 48
- •hours prior to the study.
研究者
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