To compare the blood levels and side effects between liposomal Amphotericin B Injection of Sun Pharmaceutical Industries Limited and AmBisome® of Astellas Pharma US, Inc.
- Conditions
- Health Condition 1: B550- Visceral leishmaniasis
- Registration Number
- CTRI/2019/04/018673
- Lead Sponsor
- Sun Pharmaceutical Industries Ltd India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 0
Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified.
1.Male and non-pregnant, non-lactating female subjects with 18 to 75 years (both inclusive) of age.
2.Immunocompetent subjects who need Amphotericin B treatment for no less than 5 days as part of his/her therapy for following disease condition:
a. Presence of amastigotes of leishmania on smears of bone marrow aspirate, or smears of splenic aspirate, or histology of liver, marrow, or spleen or presence of amastigotes (Leishmania Donovani bodies) detected by rK39 dipstick test, and
b. Clinical Symptoms of visceral Leishmaniasis (fever of over 2 weeks duration, weight loss and splenomegaly)
3. Subjects with life expectancy greater than or equal to 4 weeks.
4. Subject having sufficient venous access to permit administration of study drug.
5. Subjects must have clinically acceptable results from all the screening and check-in laboratory investigations.
6. Subject and/or LAR who can able to understand and provide written informed consent.
7. Able to comply with study requirements and assessments.
8. 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 with spontaneous amenorrhea for at least past 12 months (in case of Postmenopausal with spontaneous amenorrhea for at least 6 months then serum FSH level > 40 mIU/ml.
OR
Surgically sterile (subjects with bilateral tubal ligation / bilateral oophorectomy / hysterectomy)
Subjects must not be enrolled in the study if they meet any one of the following criteria:
1. Subjects with allergy or significant history of hypersensitivity or idiosyncratic reactions to any drug or excipients.
2. Subject had moderate or severe liver disease which is defined as:
(a) Transaminase (SGOT/AST or SGPT/ALT) > 10 times upper limit of normal (ULN)
(b) Total bilirubin > 5 times ULN
(c) Alkaline phosphatase > 5 times ULN
3. Subjects with Serum Creatinine > 2 x upper limit of normal.
4. Subjects with potassium levels <= 3.0 mmol/L or mEq/L.
5. Subjects who require concomitant therapy with intravenous fat emulsions, such as total parental nutrition (TPN).
6. Subjects with Hemoglobin level < 6 gm%, neutrophils <750/ mm3 and platelets <50,000 / mm3
7. Subjects with splenectomy
8. Subjects with Post-kala-azar dermal leishmaniasis.
9. Subjects who are receiving corticosteroids and corticotropin (ACTH), digitalis glycosides, azoles, other nephrotoxic medications, skeletal muscle relaxants (e.g. tubocurarine) within 30 days prior to enrollment in the study.
10. Subjects who are currently receiving or received antineoplastic agents prior to enrollment in the study.
11. Subjects who require leukocyte transfusions while receiving Amphotericin B.
12. Subjects who have shown positive result in breath alcohol test and/or urine drug screening test prior to check in
13. Subjects with history of drug or substance abuse or dependence, history of alcoholism in the past 1 year prior to screening.
14. Subjects who have donated blood or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 60 days.
15. Subjects with history of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture.
16. Subjects with history of allergic response to heparin.
17. Subjects with positive hepatitis screen (includes subtypes B & C).
18. Subjects with positive test result for HIV antibody.
19. Subjects with positive test result for syphilis (RPR/VDRL).
20. Subjects with any clinically significant ECG findings.
21. Participation in any investigational drug study within 30 days prior to first dose of study drug
22. Subjects with history of or current clinically significant medical illness including (but not limited to) cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological, or psychiatric disease or any other illness that, that the investigator considers should exclude the subject.
23. Subjects with any other medical condition or comorbid complication that, in the investigatorâ??s judgment, might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the steady state bioequivalence between Test Product (Amphotericin B Liposome for Injection 50 mg / vial of Sun Pharmaceutical Industries Limited) and Reference Product (AmBisome® (Amphotericin B) Liposome for Injection 50 mg / vial of Astellas Pharma US, Inc.) under Fed Conditions.Timepoint: At the end of the study when all 140 patients have <br/ ><br>completed the study
- Secondary Outcome Measures
Name Time Method To evaluate the safety of Test Product and Reference Product.Timepoint: At the end of the study when all 140 patients have <br/ ><br>completed the study