A comparative study to monitor the safety of Amphotericin 50mg per vial A and Ambisome (amphotericin b) 50 mg per vial B in 48 patients.
- Conditions
- Health Condition 1: null- As mentioned in inclusion criteria
- Registration Number
- CTRI/2017/03/007993
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 48
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 #.
vi.Patients must have clinically acceptable results from all the screening and check-in laboratory parameters and investigations.
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. (b)
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. or >100/min.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the bioequivalence between Test product (A) and Reference product (B) in Patients requiring Amphotericin B Liposome for Injection under fed condition.Timepoint: 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]
- Secondary Outcome Measures
Name Time Method To monitor the safety of Test product (A) and Reference product (B) in Patients requiring Amphotericin B Liposome for InjectionTimepoint: throughout study