Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition

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 …