NCT03636659

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2018

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2019

Completed
Last Updated

August 26, 2019

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

August 6, 2018

Last Update Submit

August 22, 2019

Conditions

Visceral Leishmaniasis

Outcome Measures

Primary Outcomes (2)

  • Estimation of Cmax-ss, Maximum concentration over the steady state dosing interval

    To establish bioequivalence limits within 80-125 %

    05 days

  • Estimation of AUC0-tau, Area under the plasma concentration time curve over the steady state dosing interval

    To establish bioequivalence limits within 80-125 %

    05 days

Secondary Outcomes (6)

  • Evaluation of Cmin-ss

    05 days

  • Evaluation of Cavg-ss

    05 days

  • Evaluation of tmax-ss

    05 days

  • Evaluation of Cpd

    05 days

  • Evaluation of Percentage Fluctuation

    05 days

  • +1 more secondary outcomes

Study Arms (2)

Amphotericin B Liposome

EXPERIMENTAL

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

Drug: Amphotericin B Liposome

AmBisome Liposome

ACTIVE COMPARATOR

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

Drug: AmBisome (Amphotericin B) Liposome

Interventions

Amphotericin B LiposomeDRUG

Manufactured for: Auromedics Pharma LLC, USA

Amphotericin B Liposome
AmBisome (Amphotericin B) LiposomeDRUG

Marketed by: Astellas Pharma US, Inc. USA

Also known as: AmBisome
AmBisome Liposome

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

International Centre for Diarrhoeal Disease Research b

Dhaka, 1212, Bangladesh

Location

Kala-Azar medical Research Centre

Muzaffarpur, Bihar, 842001, India

Location

Rajendra Memorial Research Institute of Medical Sciences

Patna, Bihar, 800007, India

Location

MeSH Terms

Conditions

Leishmaniasis, Visceral

Interventions

Amphotericin Bliposomal amphotericin BLiposomes

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic ChemicalsMembranes, ArtificialBiomedical and Dental MaterialsDrug CarriersDosage FormsPharmaceutical PreparationsManufactured MaterialsTechnology, Industry, and AgricultureBiomimetic Materials

Study Officials

  • Nagesh Meda, M.Pharm

    Aurobindo Pharma Ltd

    STUDY CHAIR

  • Dr. Subhra Lahiri, Ph.D

    Axis Clinicals Limited

    STUDY DIRECTOR

  • Dr. Sajid Mohd, MD

    Axis Clinicals Limited

    STUDY DIRECTOR

  • Dr. Krishna Pandey, MD

    Rajendra Memorial Research Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Dr. Shyam Sundar, MD

    Kala-Azar medical Research Centre

    PRINCIPAL INVESTIGATOR

  • Dr. Dinesh Mondal, MD

    International Centre for Diarrhoeal Disease Research b

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 17, 2018

Study Start

May 2, 2018

Primary Completion

April 5, 2019

Study Completion

April 5, 2019

Last Updated

August 26, 2019

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

BA(1)IN(2)