CTRI/2024/01/062043招募中Unknown
An open label randomized two treatments two sequences two periods single dose crossover bioequivalence study of Liposomal Amphotericin B powder for solution for Infusion, 50 mg pervial of Bharat Serums and Vaccines Ltd, India and AmBisome 50mg per vial marketed by Gilead in healthy volunteers - NI
Bharat Serums and Vaccines Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
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
- •BMI 18.5 to 29.9 kg per m2 and weight more than 50 kg
- •Healthy volunteers
- •Normal or clinical insignificant biochemical heamtological urine and serology parameters
- •normal or clinical insignificant ECG
- •Negative urine test for drugs of abuse alcohol breath analysis
- •willing to use contraception
- •willing to give informed consent and communicate effectively
排除标准
- •history of surgical procedures in past
- •history of clinical significant cardiac gastric renal endocrine neurological metabolic psychiatric hematological disorders
- •history of chronic alcoholism chronic smoking drug of abuse
- •hypersensitivity to liposomal amphotericin b or its excipients
- •history of consumption of tobacco containing products
研究者
相似试验
已完成
不适用
A study to monitor the safety and to assess thesteady-state bioequivalence of Imatinib Mesylate 400 mg tablets of SunPharmaceutical Industries Ltd, India in Chronic Myeloid Leukemia (CML) patientsCTRI/2014/03/004484Sun Pharmaceutical Industries Ltd36
已完成
Unknown
Bioequivalence study of Liposomal Amphotericin B 50 mg/vial of Bharat Serums and Vaccines Ltd.CTRI/2023/05/052602Bharat Serums and Vaccines Ltd
尚未招募
不适用
Comparative oral bioequivalence study of DICOMEX (Clozapine) 100 mg tablet ofLaboratorios Recalcine S.A., Chile and Clozaril® (Clozapine) 100 mg tablet of NovartisPharmaceutical CorporatioCTRI/2015/10/006303aboratorios Recalcine SA36
尚未招募
1 期
A Randomized, Open Label, Two Treatment, Four period, Two Sequence, Full Replicate, Single Dose, Crossover Bioequivalence Study of Entacapone GPO (200 mg) (Entacapone 200 mg Tablets) of The Government Pharmaceutical Organization, with Comtan (Entacapone 200 mg Tablets) of Orion Corporation, Finland for Novatis Pharma AG, Switzerland, in Normal, Healthy, Adult, Human Subjects Under Fasting ConditionsHealthy male and female volunteersTCTR20200302001The Government Pharmaceutical Organization36
已完成
1 期
A Phase I Clinical study to evaluate PK & PD of GeneSys Insulin Glargine.CTRI/2020/09/027956GeneSys Biologics Pvt Ltd