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
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Manufactured for: Auromedics Pharma LLC, USA
Marketed by: Astellas Pharma US, Inc. USA
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
Estimation of Cmax-ss, Maximum concentration over the steady state dosing interval
To establish bioequivalence limits within 80-125 %
Time frame: 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 %
Time frame: 05 days
Evaluation of Cmin-ss
Summary statistics, ANOVA, Ratio Analysis, 90% Confidence Interval, Inter subject variability and Power will be calculated
Time frame: 05 days
Evaluation of Cavg-ss
Summary statistics, ANOVA, Ratio Analysis, 90% Confidence Interval, Inter subject variability and Power will be calculated
Time frame: 05 days
Evaluation of tmax-ss
Summary statistics, ANOVA, Ratio Analysis, 90% Confidence Interval, Inter subject variability and Power will be calculated
Time frame: 05 days
Evaluation of Cpd
Summary statistics, ANOVA, Ratio Analysis, 90% Confidence Interval, Inter subject variability and Power will be calculated
Time frame: 05 days
Evaluation of Percentage Fluctuation
Summary statistics, ANOVA, Ratio Analysis, 90% Confidence Interval, Inter subject variability and Power will be calculated
Time frame: 05 days
Evaluation of Swing
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Summary statistics, ANOVA, Ratio Analysis, 90% Confidence Interval, Inter subject variability and Power will be calculated
Time frame: 05 days