CTRI/2019/02/017626已完成1 期
A randomized, balanced, two-treatment, two-period, two-sequence, single-dose, crossover oral bioequivalence study of Dolutegravir dispersible tablets 10 mg of Mylan Laboratories Limited, India with GSK1349572, CQ, 5.0 mg, TAB-D (2Ã?5mg) (Dolutegravir Dispersible tablets 5mg) Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ in normal healthy adult male and female (not of childbearing potential) human subjects under fed conditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
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
- •Subjects must fulfill all of the following criteria to be considered for inclusion into this study:
- •i. Normal healthy adult male and female (not of childbearing potential) human subjects, age between 18 to 45 years (inclusive of both).
- •ii. Body mass index of ï?³ 18.5 kg/m2 and ï?£ 24.9 kg/m2 and weight ï?³ 50.00 kg.
- •iii. Healthy according to the laboratory results and physical examination, performed within 21 days prior to the commencement of the dosing in Period-1.
- •iv. Subject whose clinical laboratory values are within normal limits or clinically insignificant as determined by physician or principal investigator to be of no clinical significance.
- •v. Have normal ECG, Chest X-ray and vital signs.
- •vi. Non-smoker and Non-alcoholic.
- •vii. Subject able to communicate effectively and willing to provide informed consent.
- •viii. Subject willing to adhere to protocol requirements as evidenced by informed consent approved by an Independent Ethics Committee (IEC).
- •ix. Subject is postmenopausal for at least 1 year
- •is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study subject).
排除标准
- •A subject will not be eligible for study participation if he/she meets any of the following criteria:
- •i. Any history of allergy or hypersensitivity to Dolutegravir or other related drugs.
- •ii. Positive test result for hepatitis B surface antigen (HBs Ag), hepatitis C virus antibody (HCV Ab) or HIV-1 antibody or HIV Type 2 (HIV-2) antibody (HIV Ab) or VDRL / syphilis.
- •iii. The study drug is contraindicated for medical reasons.
- •iv. Amenorrhea or irregular menstrual periods (defined unable to predict within 7 days) during past 6 months for females.
- •v. Any history or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, dermatological, neurological, psychiatric diseases or disorders and â??Clinically significant abnormal values of laboratory parametersâ??.
- •vi. Any history of bleeding disorders, peptic ulcer diseases, hemorrhoids, wounds/ ulcers.
- •vii. History or presence of drug abuse in the past one year.
- •viii. Difficulty in swallowing tablets/capsules.
- •ix. Any history of difficulty in donating blood.
- •x. Had clinically significant abnormal values of laboratory parameters.
- •xi. Blood pressure is < 100/60 and > 129/79 millimeters of mercury (Systolic blood pressure/ Diastolic blood pressure).
- •xii. Pulse rate less than 60 beats / minute and more than 100 beats / minute.
- •xiii. Usage of any prescribed medication during last 14 days and for OTC medicinal products, herbal products during the last 07 days preceding the first dosing.
- •xiv. Any clinically significant illness during 3 months before screening.
- •xv. Participation in a drug research study/donation of blood within past 90 days.
- •xvi. Alanine transaminase (ALT) > 1.5 times upper normal limit.
- •xvii. Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- •xviii. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones).
- •xix. Consideration by the investigator, for any reason that the subject is an unsuitable candidate to receive study drug.
- •Subject positive for breath alcohol test, urine screen for drugs of abuse [Cannabinoids (Marijuana / Tetra Hydro Cannabinoids-THC), Cocaine, Opiates (morphine), Amphetamine, Barbiturates and Benzodiazepines] at the time of each period check-in will be excluded from the study.
研究者
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