CTRI/2022/06/043078尚未招募未知
Single dose, randomization blinded, two-period, two-treatment, twosequence,crossover, oral bioequivalence study of Mylanâ??s Test product Abacavir, Dolutegravir and Lamivudine tablets for oral suspension 60mg/5mg/30mg with Reference Product Triumeq Dispersible Tablets (5mg GSK1349572/60mg Abacavir/30 mg Lamivudine) Manufactured for: ViiV Healthcare UK Limited, 980 Great West Road, Brentford,Middlesex, TW8 9GS, UK, in Healthy adult male and female (not of childbearing potential) human volunteers under fed conditions.
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
- •Subjects must fulfill all of the following criteria to be considered for inclusion into this study:
- •1. Normal healthy adult male and female (not of childbearing potential) human subjects, age
- •between 18 to 45 years (inclusive of both).
- •2. A female may be eligible to enter and participate in the study if she is of non-childbearing
- •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
- •documented tubal ligation, hysteroctomy or bilateral oophorectomy.
- •3. Body mass index of >= 18.5 kg/m2 and <= 24.9 kg/m2 and weight >= 50.00 kg.
- •4. Healthy according to the laboratory results and physical examination, performed within 21
- •days prior to the commencement of the dosing in Period-1.
- •5. 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.
- •6. HLA-B 5701 allele negative subjects.
- •7. Have normal ECG, Chest X-ray and vital signs.
- •8. Non-smoker and Non-alcoholic.
- •9. Subject able to communicate effectively and willing to provide informed consent.
- •10. Subject willing to adhere to protocol requirements as evidenced by informed consent
- •approved by an Independent Ethics Committee (IEC).
排除标准
- •A subject will not be eligible for study participation if he/she meets any of the following
- •1. Any history of allergy or hypersensitivity to Abacavir / Dolutegravir / Lamivudine or other related drugs.
- •2.Positive test result for or HIV-1 antibody or HIV Type 2 (HIV-2) antibody (HIV Ab) or VDRL / syphilis.
- •3. Positive hepatitis B surface antigen (HBs Ag) and hepatitis C virus antibody (HCV Ab) test results at screening or within 03 months prior to starting the study intervention are excluded
- •from the study.
- •4. Any history or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, dermatological, neurological, psychiatric diseases or disorders
- •and Clinically significant abnormal values of laboratory parameters.
- •a. Subjects with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification.
- •b. Subject has creatinine clearance of <60 mL/min
- •5. Subject having Modified Patient Health Questionnaire (PHQ)-12 questionnaires >4.
- •6. Any history of bleeding disorders, peptic ulcer diseases, hemorrhoids, wounds/ ulcers.
- •7. History or presence of drug abuse in the past one year.
- •8. Difficulty in swallowing tablets/capsules.
- •9. Any history of difficulty in donating blood.
- •10. Resting Blood pressure is < 110/70 and > 129/79 millimeters of mercury (Systolic blood pressure/ Diastolic blood pressure).
- •11. Resting Pulse rate less than 60 beats / minute and more than 100 beats / minute.
- •12. 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.
- •13. Usage of any clinically significant medications last 30 days preceding the first dosing.
- •14. Any clinically significant illness during 3 months before screening.
- •15.Participation in a drug research study/donation of blood within past 90 days.
- •16. ALT > 1.5 xULN or total bilirubin > 1.5 xULN.
- •17. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones).
- •18. Consideration by the investigator, for any reason that the subject is an unsuitable candidate to receive study drug.
- •19. Breastfeeding
- •20. Clinically significant history of psychiatric disease.
- •21. Female subject demonstrating positive for pregnancy test (performed at the time of each period check-in).
- •Subject positive for alcohol test (by using urine/ blood), urine screen for drugs of abuse
- •[Cannabinoids (Marijuana / Tetra Hydro Cannabinoids-THC), Cocaine, Opiates (morphine), Amphetamine, Barbiturates and Benzodiazepines] and pregnancy test (for female subjects only) 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 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 / 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
已完成
不适用
Bioequivalence study of Abacavir/ Dolutegravir/Lamivudine 60mg/5mg/30mg Dispersible Tablets(fasting)CTRI/2021/04/032712Mylan Laboratories Limited24
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