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

NCT03636659 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2019-08-26

No results posted yet for this study

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

Conditions

  • Visceral Leishmaniasis

Interventions

DRUG

Amphotericin B Liposome

Manufactured for: Auromedics Pharma LLC, USA

DRUG

AmBisome (Amphotericin B) Liposome

Marketed by: Astellas Pharma US, Inc. USA

Sponsors & Collaborators

  • Axis Clinicals Limited

    collaborator INDUSTRY

  • Aurobindo Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Nagesh Meda, M.Pharm · Aurobindo Pharma Ltd

  • Dr. Subhra Lahiri, Ph.D · Axis Clinicals Limited

  • Dr. Sajid Mohd, MD · Axis Clinicals Limited

  • Dr. Krishna Pandey, MD · Rajendra Memorial Research Institute of Medical Sciences

  • Dr. Shyam Sundar, MD · Kala-Azar medical Research Centre

  • Dr. Dinesh Mondal, MD · International Centre for Diarrhoeal Disease Research b

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-02
Primary Completion
2019-04-05
Completion
2019-04-05
FDA Drug
Yes

Countries

  • Bangladesh
  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03636659 on ClinicalTrials.gov