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

NCT ID: NCT03636659

Last Updated: 2019-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-02
• Study Completion Date: 2019-04-05

Brief 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

Detailed Description

Multi-Center, Open-Label, Randomized, Two treatment, Parallel, Single period, Multiple-Dose, Steady state, Global Bioequivalence study of Amphotericin B Liposome for Injection 50mg /vial of Auromedics Pharma LLC, USA and AmBisome (Amphotericin B) Liposome for Injection 50mg/vial of Astellas Pharma US, inc. in patients with Visceral Leishmaniasis under fed condition.Sufficient number of patients will be enrolled to have 140 evaluable patients. (90 to 100 patients from India and 40 to 50 patients from Bangladesh).

Conditions

Visceral Leishmaniasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Amphotericin B Liposome

Amphotericin B Liposome for Injection 50 mg/vial, intravenous infusion at a dose of 3 mg/kg/day, OD for 5 days

Group Type: EXPERIMENTAL

Amphotericin B Liposome

Intervention Type: DRUG

Manufactured for: Auromedics Pharma LLC, USA

AmBisome Liposome

AmBisome Liposome for Injection 50 mg/ vial, intravenous infusion at a dose of 3 mg/kg/day, OD for 5 days

Group Type: ACTIVE_COMPARATOR

AmBisome (Amphotericin B) Liposome

Intervention Type: DRUG

Marketed by: Astellas Pharma US, Inc. USA

Interventions

Amphotericin B Liposome

Manufactured for: Auromedics Pharma LLC, USA

Intervention Type: DRUG

AmBisome (Amphotericin B) Liposome

Marketed by: Astellas Pharma US, Inc. USA

Intervention Type: DRUG

Other Intervention Names

AmBisome

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Axis Clinicals Limited

INDUSTRY

Sponsor Role: collaborator

Aurobindo Pharma Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nagesh Meda, M.Pharm

Role: STUDY_CHAIR

Aurobindo Pharma Ltd

Dr. Subhra Lahiri, Ph.D

Role: STUDY_DIRECTOR

Axis Clinicals Limited

Dr. Sajid Mohd, MD

Role: STUDY_DIRECTOR

Axis Clinicals Limited

Dr. Krishna Pandey, MD

Role: PRINCIPAL_INVESTIGATOR

Rajendra Memorial Research Institute of Medical Sciences

Dr. Shyam Sundar, MD

Role: PRINCIPAL_INVESTIGATOR

Kala-Azar medical Research Centre

Dr. Dinesh Mondal, MD

Role: PRINCIPAL_INVESTIGATOR

International Centre for Diarrhoeal Disease Research b

Locations

International Centre for Diarrhoeal Disease Research b

Dhaka, , Bangladesh

Kala-Azar medical Research Centre

Muzaffarpur, Bihar, India

Rajendra Memorial Research Institute of Medical Sciences

Patna, Bihar, India

Countries

Bangladesh; India

Other Identifiers

CTRI/2018/04/013350

Identifier Type: OTHER

Identifier Source: secondary_id

CR179-17

Identifier Type: -

Identifier Source: org_study_id