CTRI/2017/03/007993尚未招募不适用
A randomized, open label, two treatment, one period, multiple dose, steady-state, parallel, bioequivalence study of amphotericin b liposome for injection 50 mg per vial of sun pharmaceutical industries limited and ambisome (amphotericin b) liposome for injection 50 mg per vial of Astellas pharma in 48 patients under fed condition
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- To assess the bioequivalence between Test product (A) and Reference product (B) in Patients requiring Amphotericin B Liposome for Injection under fed condition.
研究概览
简要总结
This study is a randomized, open label, two treatment, one period, multiple dose, steady-state, parallel, bioequivalence study of Amphotericin b liposome for injection 50 mg / vial of sun pharmaceutical industries limited and Ambisome (amphotericin b) liposome for injection 50 mg / vial of astellas pharma in 48 (24+24) patients under fed condition
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •i.Patients who need Amphotericin B treatment for no less than 5 days as part of his/her therapy as per Appendix IV.
- •Any of the below patients category can be enrolled (a) Patients with cryptococcal Meningitis with HIV infection (b)Febrile, neutropenic patients that require empirical therapy for presumed fungal infection (c)Patients with Aspergillus species, Candida species and/or Cryptococcus species infections [see above (a) for Cryptococcal Meningitis] refractory to Amphotericin B Deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of Amphotericin B Deoxycholate.
- •(d)Patients with visceral leishmaniasis (Immunocompetent & Immunocompromised patients, to be decided at the discretion of Investigator) ii.
- •Patient whose age is in between 18-75 years (Limits inclusive).
- •iii.Patient willing to give written consent (Patient Information Sheet and Informed Consent Form) prior to enrolment in the study.
- •iv.Patients whose life expectancy is greater than or equal to 6 months.
- •v.Patients with Performance less than or equal to 2 on the ECOG performance scale #.
- •vii.Availability of patient for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
- •viii.Subjects •of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as birth control pills (if taken for at least 3 months prior to receiving the study medication), progestin injection or implants, condom plus spermicide, diaphragm plus spermicide, IUD, or vaginal spermicidal suppository or abstinence from sexual activity.
- •OR •Postmenopausal for at least past 12 months.
- •OR •Surgically sterile (bilateral tubal ligation / bilateral oophorectomy / hysterectomy has been performed on the subject).
- •# Applicable for patient population mentioned in inclusion criterion i.
排除标准
- •i.Patient with a history of or current clinically significant medical illness including (but not limited to) cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological, or psychiatric disease or any other illness that the investigator considers should exclude the patient.
- •ii.Patients with clinical evidence of acute or chronic meningitis due to an agent other than Cryptococcus neoformans [For HIV Infected patient only].
- •Patients who have evidence of underlying disease which in the judgment of the investigator would make the patient inappropriate for getting enrolled in the study (except inclusion criteria point i, a, b, c, d) during screening medical history.
- •iii.Patient with a comorbid complication with anticipated difficulty in protocol compliance in the opinion of the investigator as a result of the comorbid complication or the drugs used to treat it.
- •iv.Patient with Suspected or active tuberculosis (TB).
- •v.Allergy or Significant history of hypersensitivity or idiosyncratic reactions to any drug or excipients of conventional or Liposomal Amphotericin B formulations.
- •vi.Patients who have shown positive result in breath alcohol test and/or urine drug screening test prior to check in.
- •vii.Patients with serum creatinine concentration >2 x the upper limit of normal (ULN) or ASAT/ALAT value >10 x ULN.
- •viii.Clinically significant illness (except inclusion criteria point i, a, b, c, d) within 4 weeks before the start of the study.
- •ix.Patients with a history of alcohol, drug or substance abuse in the past 12 months.
- •x.Patients who have used enzyme modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Griseofulvin etc.) within 30 days of first dosing.
- •xi.Patients deemed uncooperative or noncompliant.
- •xii.Patients who smoke (≥ 10 cigarettes/day or equivalent) or consume tobacco products (≥ 4 chews of any form/day).
- •xiii.Female patient who is pregnant, lactating or likely to become pregnant or have a positive pregnancy test at screening or during check-in.
- •xiv.Difficulty in coming for follow up.
- •xv.Patients who have participated in another clinical study for at least 90 days prior to first dosing.
- •xvi.Blood donation within 90 days prior to first dosing.
- •xvii.Patients who have: Systolic blood pressure <90 mm of Hg or >140 mm of Hg Diastolic blood pressure <60 mm of Hg or >90 mm of Hg Minor deviations (2-4mm Hg) at check-in may be acceptable at the discretion of the investigator.
- •Radial pulse rate <60/min.
结局指标
主要结局
To assess the bioequivalence between Test product (A) and Reference product (B) in Patients requiring Amphotericin B Liposome for Injection under fed condition.
时间窗: at-48.000 [on Day 03] and at -24.000 [Day 04] and 0.000 [on Day 05] hrs within a period of 5 minutes prior to start of infusion (at same time from each dose) at respective days.Post-dose blood samples (3 mL each) will be collected at 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 6.000, 8.000, 12.000, 18.000 and 24.000 hours after the start of infusion [on Day 05]
次要结局
- To monitor the safety of Test product (A) and Reference product (B) in Patients requiring Amphotericin B Liposome for Injection(throughout study)
研究者
研究点 (3)
Loading locations...
相似试验
尚未招募
早期 1 期
An Relative Bioavailability Study of BH006 for Injection in Healthy SubjectsBioavailabilityNCT06427681Zhuhai Beihai Biotech Co., Ltd40
已完成
1 期
Bioequivalence Study of Metformin Hydrochloride Extended-Release Tablets USP 750 mg Under Fasting ConditionFastingNCT01831661IPCA Laboratories Ltd.48
已完成
1 期
Bioequivalence Study of Metformin Hydrochloride Extended-Release Tablets USP 750 mg Under Fed ConditionFastingNCT01831674IPCA Laboratories Ltd.48
已完成
不适用
Bioequivalence Study of Valsartan 320mg Tablets Under Fed ConditionsHealthyNCT02197494Ranbaxy Laboratories Limited40
已完成
1 期
Bioequivalence Study of Allopurinol 300 mg Tablets USP Under Fasting ConditionFasting StateNCT01603134IPCA Laboratories Ltd.32