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

• Status: Completed
• Trial end date: 2019-04-05
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aurobindo Pharma Ltd
• Collaborator: Axis Clinicals Limited
• Treatments: Amphotericin B; Liposomal amphotericin B

Criteria

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