A study to compare Cipla product- Amphotericin B with Gilead product- Ambisome to establish that both are equally effective in treating Kala Azar patients.
- Conditions
- Health Condition 1: null- Visceral Leishmaniasis
- Registration Number
- CTRI/2017/05/008656
- Lead Sponsor
- Cipla Ltd India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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 <1%), for e.g. vaginal ring, injectable progesterone or transdermal patches
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
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Establish bioequivalance between Cipla product and comparatorTimepoint: 5 days
- Secondary Outcome Measures
Name Time Method To monitor the safety of the patients who are exposed to the Investigational Medicinal Product.Timepoint: 5 days