CTRI/2018/04/013350已完成未知
A Multi-Center Open-Label Randomized Two treatment Parallel Single period Multiple-Dose Steady state Global Bioequivalence study of Amphotericin B Liposomefor Injection 50mg vial (Test) of Auromedics Pharma LLC USA and AmBisome (Amphotericin B) Liposomefor Injection 50mg/vial (Reference) of Astellas Pharma US, inc in patients with Visceral Leishmaniasisunder fed (non-high fat breakfast) condition
APL Research Center Aurobindo Pharma Limited0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 100
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
- •Inclusion criteria
- •1.Male and female patients aged between 18 to 65 years (both inclusive).
- •2.Clinical signs and symptoms of Visceral Leishmaniasis (fever of over 2 weeks duration, weight loss and splenomegaly).
- •3.Presence of amastigotes (Leishmania Donovani bodies) at prescreening detected by rK39 dipstick test.
- •4.Female subjects of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, i.e. barrier method, intrauterine device, or tubal ligation.
- •5.Ability to comply with all study requirements.
- •6.Patients with Hb >= 6.0 g/dl
- •7.Patients with platelets count >= 50000/mm3
- •8.Patients and/ or LAR must be give written informed consent
- •Patients with clinically acceptable results from all the screening laboratory parameters and investigations.
排除标准
- •Exclusion Criteria:
- •1.Known allergy or hypersensitivity reactions to any components of conventional or liposomal Amphotericin B formulations.
- •2.Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up.
- •3.Pregnant or lactating women
- •4.Patients requiring dose adjustment during the study.
- •5.Serum creatinine concentration greater than twice the upper limit of normal (ULN), AST or ALT value greater than 10 times the ULN
- •6.Patients who are required to be on concomitant therapy with IV fat emulsions, such as total parental nutrition (TPN).
- •7.Patients with total bilirubin levels > 3 times the upper normal limits (i.e. > 3.0 mg/dl).
- •8.Patient with clinically significant Hematopoietic, renal, hepatic and electrolyte disorders (Low level of Magnesium and potassium) will be excluded as per the discretion of Investigator
- •9.Patients with Clinically significant screening laboratory parameters in the opinion of the investigator.
- •10.Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
- •11.History of uncontrolled diseases, such as thyroidal dysfunction, angina pectoralis, serious cardiac arrhythmias, serious heart failure, neuropsychiatric infection or disease.
- •12.Patients with controlled and uncontrolled diabetes mellitus
- •13.Patients with Uncontrolled hypertension will be excluded.
- •14.Patients with known positivity for human immunodeficiency virus (HIV), HBsAg and HCV.
- •15.Positive results for drugs of abuse (benzodiazepines, opioids, amphetamines, cannabinoids, cocaine and barbiturates) in urine.
- •16.Positive results for alcohol as detected by alcohol breath analyzer.
- •17.History of difficulty with donating blood or difficulty in accessibility of veins.
- •18.An unusual or abnormal diet, for whatever reason e.g. religious fasting.
- •19.History of donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study
研究者
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