Health Condition 1: null- Visceral Leishmaniasis
Conditions
Interventions
Intervention1: Cipla Amphotericin B
: Liposome for Injection
Dose: 3mg/kg/day or 4mg/kg/day
Frequency: Once a day
Route of Administration: IV
Total duration of therapy: 5 days
Control Intervention1
Sponsors
Cipla Ltd India
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients who have signed informed consent form before initiation of any study related procedure. 2) Male and female patients who are >18 years of age at the time informed consent is obtained. 3) Patients with visceral leishmaniasis. 4) Able to comply with all the study procedures as per protocol. 5) Patients with clinically insignificant laboratory values of hepatic, renal, hematopoietic and serum electrolytes at screening. 6) The patient must be able to maintain the same regimen of the concomitant medications during the entire study.
Exclusion criteria
Exclusion criteria: 1) History of hypersensitivity reactions to any components of conventional or liposomal Amphotericin B formulations. 2) Patients who require dose adjustment during the study. 3) Patients requiring any other concomitant drugs which have PK interaction with IMP. 4) Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (e.g.,congestive heart failure, known aortic aneurysm,clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal,hematological, neuropsychological, endocrine (e.g.,uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addisonâ??s disease, Cushingâ??s syndrome),gastrointestinal (e.g., poorly-controlled peptic ulcer, gastroesophageal reflux disease [GERD]), or pulmonary (e.g., chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease [COPD]) or obstructive sleep apnoea. 5) Use of any investigational drug (approved or unapproved) within 30 days or 5 half-lives (whichever is longer) preceding the screening or planned participation in another investigational drug study at any time during this study. 6) Donation / loss of blood (without replenishment) (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medicine. 7) Patients with any abnormal/clinically significant lab value/s which may impair the safety during the study. 8) Female patient who is pregnant or lactating. Pregnancy defined as state of a female after conception and until the termination of gestation (confirmed by positive serum/urine pregnancy test), lactating, or plans to become pregnant, or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the patientâ??s last study related visit. 9) Women of childbearing potential unwilling to employ effective contraceptive methods or if they are of non-childbearing potential as defined below. ï? Methods of contraception include: i. Total abstinence (periodic abstinence and withdrawal are not acceptable contraceptive methods) ii. Surgical sterilization (tubal ligation, bilateral oophorectomy, or hysterectomy) at least 6 weeks before screening iii. Vasectomized male (done at least 6 months prior to screening) should be the sole partner for the female patient iv. Congenital sterility v. Use of oral, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate vi. Double barrier methods (condoms, cervical cap, diaphragm and vaginal contraceptive film with spermicide) vii. Intrauterine device (IUD) ï? Women of non-childbearing potential defined as: i. Surgical or congenital sterility ii. >1 year natural (spontaneous) amenorrhea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establish bioequivalance between Cipla product and comparatorTimepoint: 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the patients who are exposed to the Investigational Medicinal Product.Timepoint: 5 days | — |
Countries
India
Contacts
Public ContactDr Piyush Agarwal
Cipla Ltd.
Outcome results
None listed