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

This is an interventional treatment trial for Visceral Leishmaniasis Read More

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 nutrition (TPN).
• Patients with total bilirubin levels > 3 times the upper normal limits (i.e. > 3.0 mg/dl).
• Patient with clinically significant Hematopoietic, renal, hepatic and electrolyte disorders (Low level of Magnesium and potassium) will be excluded as per the discretion of Investigator
• Patients with Clinically significant screening laboratory parameters in the opinion of the investigator.
• Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
• History of uncontrolled diseases, such as thyroidal dysfunction, angina pectoralis, serious cardiac arrhythmias, serious heart failure, neuropsychiatric infection or disease.
• Patients with controlled and uncontrolled diabetes mellitus
• Patients with Uncontrolled hypertension will be excluded.
• Immunocompromised patients will be excluded from participating the study
• Patients with known positivity for human immunodeficiency virus (HIV), HBsAg and HCV.
• Positive results for drugs of abuse (benzodiazepines, opioids, amphetamines, cannabinoids, cocaine and barbiturates) in urine.
• Positive results for alcohol as detected by alcohol breath analyzer.
• History of difficulty with donating blood or difficulty in accessibility of veins.
• An unusual or abnormal diet, for whatever reason e.g. religious fasting.
• History of donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study