CTRI/2021/04/032730已完成未知
Single dose, randomization blinded, two period, two sequence, oral bioequivalence study of Mylanâ??s Abacavir / Dolutegravir / Lamivudine (60 mg / 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 Healthy adult male and female (not of childbearing potential) human volunteers under fed conditions.â??
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 36
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
- •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 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
- •3. Body mass index of ï?³ 18.5 kg/m2 and ï?£ 24.9 kg/m2 and weight ï?³ 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 criteria:
- •1. Any history of allergy or hypersensitivity to Abacavir / Dolutegravir /
- •Lamivudine or other related drugs.
- •2. 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.
- •3. 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??.
- •I) Subjects with moderate to severe hepatic impairment (Class B or greater)
- •as determined by Child-Pugh classification
- •II) Subject has creatinine clearance of <50 mL/min
- •4. Subject having Modified Patient Health Questionnaire (PHQ)-12
- •questionnaires >4.
- •5. Any history of bleeding disorders, peptic ulcer diseases, hemorrhoids,
- •wounds/ulcers.
- •6. History or presence of drug abuse in the past one year.
- •7. Difficulty in swallowing tablets/capsules.
- •8. Any history of difficulty in donating blood.
- •9. Resting Blood pressure is < 100/60 and > 129/79 millimeters of mercury
- •(Systolic blood pressure/ Diastolic blood pressure).
- •10. Pulse rate less than 60 beats / minute and more than 100 beats / minute.
- •11. 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.
- •12. Usage of any clinically significant medications last 30 days preceding the first dosing.
- •13. Any clinically significant illness during 3 months before screening.
- •14. Participation in a drug research study/donation of blood within past 90 days.
- •15. ALT greaterthan equals to 1.5 ULN or total bilirubin ALT greaterthan equals to 1.5.
- •16. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of
- •Gilbert s syndrome or asymptomatic gallstones).
- •17. Consideration by the investigator, for any reason that the subject is an unsuitable candidate to receive study
- •18. Female subject demonstrating positive for pregnancy test (performed at the time of period-01 check-in).
- •19. 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
Bioequivalence study of Abacavir/ Dolutegravir/Lamivudine 60mg/5mg/30mg Dispersible Tablets(fasting)CTRI/2021/04/032712Mylan Laboratories Limited24
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