CTRI/2021/04/032712已完成未知
Single dose, randomization blinded, two period, two sequence, oral bioequivalence study of Mylanâ??s Abacavir / Dolutegravir / Lamivudine (60mg / 5 mg / 30 mg) Dispersible Tablets with Refernce Product (R):GSK1349572 5 mg (Dolutegravir dispersible tablets) Manufactured for: ViiV Healthcare UK limited, 980 Great West Road, Brentford, TW8 9GS at Manufacturing site: Glaxo Operations UK Limited, Priory Street, Ware, Hertfordshire, SG12 0DJ and Abacavir and Lamivudine Tablets for Oral suspension 60/30mg of Mylan Laboratories Limited, India., in Healthyadult male and female (not of childbearing potential) human volunteers under fasting conditions.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 24
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
- •Normal healthy adult male and female (not of childbearing potential) human subjects, age between 18 to 45 years (inclusive of both)
- •A female, may be eligible to enter and participate in the study if she is of nonchild-bearing 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
- •Body mass index of ï?³ 18.5 kg/m2 and ï?£ 24.9 kg/m2 and weight ï?³ 50.00 kg.
- •Healthy according to the laboratory results and physical examination, performed within 21 days prior to the commencement of the dosing in Period-1.
排除标准
- •A subject will not be eligible for study participation if he/she meets any of the following
- •Any history of allergy or hypersensitivity to Abacavir / Dolutegravir /
- •Lamivudine or other related drugs.
- •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.
- •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??.
- •â?? Subjects with moderate to severe hepatic impairment (Class B or
- •greater) as determined by Child-Pugh classification
- •â?? Subject has creatinine clearance of <50 mL/min
- •Subject having Modified Patient Health Questionnaire (PHQ)-12
- •questionnaires >4.
- •Any history of bleeding disorders, peptic ulcer diseases, hemorrhoids, wounds/ ulcers.
- •History or presence of drug abuse in the past one year.
- •Difficulty in swallowing tablets/capsules.
- •Subject having Modified Patient Health Questionnaire (PHQ)-12 questionnaires >4.
- •Any history of bleeding disorders, peptic ulcer diseases, hemorrhoids, wounds/ ulcers.
- •History or presence of drug abuse in the past one year.
- •Difficulty in swallowing tablets/capsules.
- •Any history of difficulty in donating blood.
- •Resting Blood pressure is < 100/60 and > 129/79 millimeters of mercury (Systolic blood pressure/ Diastolic blood pressure).
- •Pulse rate less than 60 beats / minute and more than 100 beats / minute.
- •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.
- •Usage of any clinically significant medications last 30 days preceding the first dosing.
- •Any clinically significant illness during 3 months before screening.
- •Participation in a drug research study/donation of blood within past 90 days.
- •ALT greterthan equalto 1.5 ULN or total bilirubin ALT greterthan equalto1.5.
- •Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert s syndrome or asymptomatic gallstones).
- •Consideration by the investigator, for any reason that the subject is an unsuitable candidate to receive study drug.
- •Female subject demonstrating positive for pregnancy test (performed at the time of period-01 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
相似试验
尚未招募
不适用
bioequivalence study of Abacavir / Dolutegravir / Lamivudine (60 mg / 5 mg / 30 mg) Dispersible Tablets in Healthy adult male and female (not of childbearing potential) human volunteers under fed conditions.CTRI/2021/04/033145Mylan Laboratories Limited
已完成
不适用
Single dose, randomization blinded, two period, two sequence, oral bioequivalence study of Abacavir / Dolutegravir / Lamivudine (60 mg / 5 mg / 30 mg) Dispersible Tablets in Healthy adult male and female (not of childbearing potential) human volunteers under fed conditions.CTRI/2021/04/032730Mylan Laboratories Limited36
尚未招募
不适用
Bioequivalence study of Abacavir, Dolutegravir and Lamivudine tablets for oral suspension 60mg/5mg/30mg (fasting)CTRI/2022/06/043058Mylan Laboratories Limited
尚未招募
不适用
Bioequivalence study of Abacavir, Dolutegravir and Lamivudine tablets for oral suspension 60mg/5mg/30mg in Healthy adult male and female (not of childbearing potential) human volunteers under fed conditionsCTRI/2022/06/043078Mylan Laboratories Limited
撤回
1 期
Comparative assessment of the absorption of a generic formulation of Dimethyl (2E)-but-2-enedioate capsule against the innovator Dimethyl (2E)-but-2-enedioate capsule conducted under fasting condition in healthy male and female volunteers.Dimethyl (2E)-but-2-enedioate is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.Neurological - Multiple sclerosisACTRN12621000775819Zenith Technology Corporation Limited39