CTRI/2019/07/020293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 Dispersible Tablet 5 mg (ViiVHealthcare, UK) in healthy, adult, male subjects.
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 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 clinically significant 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
- •The subjects will be excluded based on the following criteria:
- •1.Personal history of allergy or hypersensitivity to Dolutegravir or allied drugs or excipients.
- •2.Any major illness in the past 90 days or any clinically significant ongoing chronic medical illness
- •3.Presence of any clinically significant abnormal laboratory values during screening
- •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 and history of head trauma.
- •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 or having consumed alcohol within 48 hours prior to dosing.
- •9.Consumption of products containing xanthine derivatives or tobacco products within 48 hours prior to dosing.
- •10.Consumption of grapefruit or grapefruit containing products or any cruciferous vegetables or char-broiled meat prior 7 days.
- •11.Consumption of products containing Ca/Fe/Mg within 48 hours prior to dosing.
- •12.Use of any recreational drug or a history of drug addiction.
- •13.Participation in any clinical trial within the past 90 days.
- •14.History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm.
- •15.Donation of blood within 90 days prior to receiving the first dose of study medication.
- •16.Consumption of any other prescription drug or OTC drugs and receiving dofetilide within two weeks prior to receiving the first dose of study medication.
- •17.An unusual diet for whatever reason e.g. low sodium diet.
- •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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