CTRI/2021/04/033036已完成不适用
A Randomized, Open Label, Balanced, Two-Treatment, One-Sequence, One-Period, Multiple-Dose, Parallel Design, Steady-State Comparison Study of Test Product (T) [Remdesivir Sublingual Tablets 20 mg (Dose 200 mg/day) of Jubilant Generics Limited, India] with Reference Product (R) [Jubi-RTM (Remdesivir for injection 100 mg) (Loading Dose 200 mg/day, Maintenance Dose 100 mg/day) of Jubilant Generics Limited, India] in Healthy Adult, Human Subjects, Under Fasting Conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax,ss, Cmin,ss and AUC0-Ï„; For Nucleoside Metabolite of Remdesivir (GS-441524)
研究概览
简要总结
This study is a randomized, openlabel, balanced, two-treatment, one-sequence, one-period, multiple dose, paralleldesign steady-statecomparison study of test product (Remdesivir SublingualTablets 20 mg (Dose 200 mg/day) of Jubilant Generics Limited, India) withreference product (R) (Jubi-RTM (Remdesivir for injection 100 mg)(Loading Dose 200 mg/day, Maintenance Dose 100 mg/day) of Jubilant GenericsLimited, India) in healthy adult, human subjects, under fasting conditions.
The objective of the trail is to characterizethe pharmacokinetic exposure and to assess the steady-state comparison of thetest formulation (T) [Remdesivir Sublingual Tablet 20 mg (Dose 200 mg/day) ofJubilant Generics Limited, India] with Reference formulation (R) [Jubi-RTM(Remdesivirfor injection 100 mg) (Loading Dose 200 mg/day, Maintenance Dose 100 mg/day) ofJubilant Generics Limited, India] in healthy adult, human subjects, underfasting Conditions. Safety of the study subjects will also be monitored andevaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects between 18 – 45 years of age (both inclusive).
- •Subjects who are able to read and write the vernacular language (English/Hindi) and understand the study requirements.
- •Must have provided written informed consent voluntarily for participation in the study in the subject’s vernacular language (English/Hindi).
- •Weight between 50.00 – 80.00 Kg in case of Male (both inclusive) or 45.00 – 75.00 Kg in case of Female (both inclusive).
- •BMI 18.50 – 24.90 Kg/m2 (both inclusive).
- •Healthy as determined by medical history, clinical and laboratory examination performed within 21 days prior to admission for the study.
- •If female, and of childbearing potential (defined as a pre-menopausal female who is biologically capable of becoming pregnant), the subject must agree to practice a medically acceptable form of contraception from admission till close out visit of the clinical study.
- •Acceptable forms of contraception include intrauterine devices, implant-able devices, and barrier methods.
- •If a barrier method is chosen, a double barrier (e.g., condom plus foam) is required.
排除标准
- •Known hypersensitivity or idiosyncratic reaction to Remdesivir, its excipients or similar classes of drugs.
- •Any evidence of significant abnormalities upon physical or clinical examination.
- •Laboratory values, which are significantly different from pre-defined reference ranges and judged clinically significant.
- •Consumption of grapefruit juice/ grapefruit at least 48-hours prior to admission.
- •Any clinically significant abnormality in Chest X-Ray (PA view).
- •Any clinically significant abnormality in ECG.
- •Evidence of QT prolongation, QTc (Rate adjusted QT interval) > 450ms (in case of male) or 460ms (in case of female)
- •Serum alanine transaminase (ALT) levels above 2x upper limit of normal (ULN) or total bilirubin > 1.3x ULN or Serum creatinine levels above 1.5x upper limit of normal.
- •History of treatment with antiplatelet/anticoagulant/fibrinolytic agents.
- •Past or present use of tobacco and nicotine in any form.
- •History of drug dependence or excessive alcohol intake on a habitual basis, or, inability to abstain from alcohol for the entire duration of study period.
- •History or presence of significant gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological, hematologic, or endocrine disease.
- •History of allergy to Heparin, dye and preservatives.
- •History or presence of any chronic illnesses such as arthritis, asthma, epilepsy, hypertension, glaucoma etc.
- •Positive result for drug(s) of abuse testing (amphetamines, barbiturates, benzodiazepines, tetrahydrocannabinol, morphine, and cocaine) in urine.
- •Positive test for alcohol upon breath analyser testing.
- •History or presence of any allergic illness including allergic skin diseases, allergic asthma and drug-induced allergy, e.g., allergy due to amoxicillin, ampicillin, penicillin, tetracycline and Non-steroidal anti-inflammatory drugs (like ibuprofen and naproxen) etc.
- •History of intake/administration of any investigational treatment in a clinical study within last 90 days prior to the onset of the study admission.
- •History of significant blood loss (≥ 350 mL) due to any reason, including blood donation within last 90 days prior to admission of the study.
- •History or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
- •Existence of any surgical or medical condition which in the judgement of Principal Investigator/Designee might interfere with the absorption, distribution, metabolism or elimination of the study drug, or, is likely to compromise the safety of subject.
- •Intake of any enzyme-modifying drugs such as cimetidine, theophylline, benzodiazepines, ranitidine, repaglinide, midazolam, proton pump inhibitors, antacids, erythromycin, diuretics, ketoconazole, anti-hypertensive drugs, dopamine agonists, busulfan, bile acid sequestrants, aluminum containing antacids, agents metabolized by CYP3A4, CYP2C8 and CYP1A2, agents Inducing UDP-glucuronosyltransferase (UGT) Metabolism, Cholestyramine etc.
- •within 30 days of study drug administration, or, administration/intake of any prescription or OTC drug including vitamins and natural supplements within 30 days of study drug administration.
- •In such cases, subject selection will be at the discretion of the Principal Investigator/Designee.
- •Intake of unusual diet for two weeks prior to admission and not willing to avoid consumption of such diet till the completion of close-out visit of the study.
- •In suchcases, subject selection will be at the discretion of the Principal Investigator/Designee.
- •Female subjects whose menstrual cycle coincides with the dosing day during the study period.
- •Pregnant and lactating females.
结局指标
主要结局
Cmax,ss, Cmin,ss and AUC0-Ï„; For Nucleoside Metabolite of Remdesivir (GS-441524)
时间窗: Day 0 to Day 4: Pre Dose (0.00 hours) | Day 4: 0.00, 0.085, 0.25, 0.5, 0.75, 1.0, 1.25, 1.50, 1.75, 2.0, 2.25, 2.5, 2.75, 3.0, 3.25, 3.5, 3.75, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0 and 24.0 hours post dose
次要结局
- Tmax,ss, Cpd, Cav, T1/2el, Keland fluctuation; For Nucleoside Metabolite of Remdesivir(Time Points: Day 0 to Day 4: Pre Dose (0.00 hours))
研究者
研究点 (1)
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