CTRI/2019/06/019834已完成未知
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, Hyderabad with GSK1349572 (Dolutegravir) 5mg/DISP TAB Site of manufacture: GSK GMS ware United Kingdom, in normal healthy adult male and female (not of childbearing potential) human subjects under fasting conditions.
试验速览
- 阶段
- 未知
- 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 greater than or eual to 18.5 kg/m2 and less than or eual to 24.9 kg/m2 and weight greater than or eual to 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. 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??.
- •v. Any history of bleeding disorders, peptic ulcer diseases, hemorrhoids, wounds/ ulcers.
- •vi. History or presence of drug abuse in the past one year.
- •vii. Difficulty in swallowing tablets/capsules.
- •viii. Any history of difficulty in donating blood.
- •ix. Had clinically significant abnormal values of laboratory parameters.
- •x. Blood pressure is < 100/60 and > 129/79 millimeters of mercury (Systolic blood pressure/ Diastolic blood pressure).
- •xi. Pulse rate less than 60 beats / minute and more than 100 beats / minute.
- •xii. 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.
- •xiii. Any clinically significant illness during 3 months before screening.
- •xiv. Participation in a drug research study/donation of blood within past 90 days.
- •xv. Alanine transaminase (ALT) > 1.5 times upper normal limit.
- •xvi. Total bilirubin levels not in normal reference interval.
- •xvii. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones).
- •xviii. Consideration by the investigator, for any reason that the subject is an unsuitable candidate to receive study drug.
- •xix. Female subject demonstrating positive for pregnancy test (performed at the time of each period check-in).
- •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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