CTRI/2021/04/033145尚未招募未知
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 and 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, SG120DJ and Ziagen (Abacavir) tablets 300mg and Epivir (Lamivudine) tablet 150 mg Manufactured for: ViiV Healthcare Research Triangle Park, NC27709 Manufactured by : GlaxoSmithKline Research Triangle Park, NC27709, 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
- •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 Have normal ECG, Chest X-ray and vital signs.
- •7. Non-smoker and Non-alcoholic.
- •8. Subject able to communicate effectively and willing to provide informed consent.
- •9. 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 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 during 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).Consideration by the investigator, for any reason that the subject is an unsuitable candidate to receive study drug.
- •17. Female subject demonstrating positive for pregnancy test (performed at the time of period-01 check-in).
- •18. 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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不适用
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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
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