The primary objective is to determine clinical bioequivalence of Amphotericin B liposome for injection of Auromedics Pharma LLC, USA and AmBisome (Amphotericin B) liposome for injection of Astellas Pharma US, Inc., in patients with Visceral Leishmaniasis under fed condition
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female patients aged between 18 to 65 years (both inclusive)
* Clinical signs and symptoms of Visceral Leishmaniasis (fever of over 2 weeks duration, weight loss and splenomegaly)
* Presence of amastigotes (Leishmania Donovani bodies) at screening detected by rK39 dipstick test.
* Female subjects of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, i.e. barrier method, intrauterine device, or tubal ligation.
* Ability to comply with all study requirements.
* Patients with Hb ≥ 6.0 g/dl
* Patients with platelets count ≥ 60,000/mm3
* Patients should be immunocompetent (e.g., white blood cell count ≥ 2500/ mm3)
* Patients and/ or LAR must be give written informed consent
* Patients with clinically acceptable results from all the screening laboratory parameters and investigations.
Exclusion Criteria:
* Known allergy or hypersensitivity reactions to any components of conventional or liposomal Amphotericin B formulations.
* Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up.
* Pregnant or lactating women
* Patients requiring dose adjustment during the study.
* Serum creatinine concentration greater than twice the upper limit of normal (ULN), AST or ALT value greater than 10 times the ULN
* Patients who are required to be on concomitant therapy with IV fat emulsions, such as total parental …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Estimation of Cmax-ss, Maximum concentration over the steady state dosing interval
Timeframe: 05 days
2
Estimation of AUC0-tau, Area under the plasma concentration time curve over the steady state dosing interval