NCT03636659View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

May 2, 2018

Primary Completion Date

April 5, 2019

Study Completion Date

April 5, 2019

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

Trial Locations (3)

1212

International Centre for Diarrhoeal Disease Research b, Dhaka

800007

Rajendra Memorial Research Institute of Medical Sciences, Patna

842001

Kala-Azar medical Research Centre, Muzaffarpur

Sponsors

Collaborators (1)

Axis Clinicals Limited
All Listed Sponsors
collaborator

Axis Clinicals Limited

INDUSTRY

lead

Aurobindo Pharma Ltd

INDUSTRY

NCT03636659 - Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition | Biotech Hunter | Biotech Hunter