CTRI/2019/08/020753已完成1 期
A Phase 1, double-blind, randomized, placebo controlled study to assess the safety,tolerability and pharmacokinetics of single and multiple doses of AS012 administered orally inhealthy subjects.
Sun Pharmaceutical Industries Ltd SPI0 个研究点目标入组 167 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 167
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Healthy male and female subjects between 18-45 years (both inclusive) of age at screening,
- •having weight at least 50kg and Body Mass Index (BMI) within 18.50 â?? 30.00 (kg/m2) (both
- •inclusive).
- •2. Voluntarily given informed consent to participate in this study.
排除标准
- •1. Female subjects who are pregnant or lactating.
- •2. History of hypersensitivity to test articles or related substances.
- •3. History of viral, systemic, fungal, bacterial or protozoal infection (flu-like symptoms (cough, fever) within 4 weeks before Screening.
- •4. Evidence of organ dysfunction or any clinically significant deviation in clinical examination or laboratory determinations.
- •5. Presence of medical illness including, but not limited to gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological, psychiatric or hematological disease, diabetes or glaucoma.
- •6. Inability to communicate well (i.e. language problem, poor mental development, psychiatric
- •illness or poor cerebral function) that may impair the ability to provide written informed
- •7. Use of any medication within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug and anticipated need of use during the study.
- •8. Subjects who have participated in another clinical study within 90 days prior to dosing in Period-1 or blood donation of 350 ml or more within 90 days prior to dosing in period 1.
- •9. Subjects with a current or past history of drug or substance and/alcohol abuse.
- •10. Subject who have shown positive result in breath alcohol and/or urine drug screening test at check in of any period.
- •11. Current smoking or use of tobacco products or substitutes.
- •12. Subject determined by the study physician to have any medical condition that could jeopardize their health or prejudice the results (e.g. history of surgery of the gastro-intestinal tract, which may interfere with absorption, except for appendectomy)
- •13. Subjects who refuse to refrain from strenuous physical work or exercise from Screening until the end of study visit.
研究者
相似试验
尚未招募
1 期
To evaluate the safety, tolerability and pharmacokinetics of single-dose and multiple-dose administration of MKP 10241CTRI/2021/09/036637Mankind Pharma Limited
已完成
不适用
A phase 1, randomized, double blind, placebo controlled, multiple ascending dose, safety and pharmacodynamic study of MDV1634 in patients with Parkinson*s disease.Parkinson's diseaseNL-OMON42429Medivation, Inc. and its Subsidiaries24
进行中（未招募）
不适用
Study to evaluate the safety of Rotarix™ in Chinese childreRotavirus gastroenteritisEUCTR2015-001547-37-Outside-EU/EEAGlaxoSmithKline Biologicals50
进行中（未招募）
1 期
First-in-Human study of a medication called ALG-020572 to determine how it works in people with Chronic Hepatitis BChronic viral hepatitis BInfections and InfestationsHep B, HBVISRCTN13113768Aligos Therapeutics, Inc.112
已完成
不适用
A Phase 1, Randomized, Double-blind, Placebo controlled, Crossover Study to Evaluate the Pharmacodynamic Effects of VX*150 in Healthy Male AdultsPain10029305NL-OMON46528Vertex Pharmaceuticals20