Health Condition 1: null- Visceral Leishmaniasis in adult patients
Conditions
Interventions
Intervention1: Liposomal Amphotericin B
3mg/kg/day for 5days
: The study will consist of single period. Each eligible patient will receive either test or reference drug for five consecutive days unde
Sponsors
APL Research Center Aurobindo Pharma Limited
AXIS Clinicals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Male and female patients aged between 18 to 65 years (both inclusive). 2. Clinical signs and symptoms of Visceral Leishmaniasis (fever of over 2 weeks duration, weight loss and splenomegaly). 3. Presence of amastigotes (Leishmania Donovani bodies) at prescreening detected by rK39 dipstick test. 4. 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. 5. Ability to comply with all study requirements. 6. Patients with Hb >= 6.0 g/dl 7. Patients with platelets count >= 50000/mm3 8. 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
Exclusion criteria: Exclusion Criteria: 1. Known allergy or hypersensitivity reactions to any components of conventional or liposomal Amphotericin B formulations. 2. Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up. 3. Pregnant or lactating women 4. Patients requiring dose adjustment during the study. 5. Serum creatinine concentration greater than twice the upper limit of normal (ULN), AST or ALT value greater than 10 times the ULN 6. Patients who are required to be on concomitant therapy with IV fat emulsions, such as total parental nutrition (TPN). 7. Patients with total bilirubin levels > 3 times the upper normal limits (i.e. > 3.0 mg/dl). 8. 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 9. Patients with Clinically significant screening laboratory parameters in the opinion of the investigator. 10. Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent. 11. History of uncontrolled diseases, such as thyroidal dysfunction, angina pectoralis, serious cardiac arrhythmias, serious heart failure, neuropsychiatric infection or disease. 12. Patients with controlled and uncontrolled diabetes mellitus 13. Patients with Uncontrolled hypertension will be excluded. 14. Patients with known positivity for human immunodeficiency virus (HIV), HBsAg and HCV. 15. Positive results for drugs of abuse (benzodiazepines, opioids, amphetamines, cannabinoids, cocaine and barbiturates) in urine. 16. Positive results for alcohol as detected by alcohol breath analyzer. 17. History of difficulty with donating blood or difficulty in accessibility of veins. 18. An unusual or abnormal diet, for whatever reason e.g. religious fasting. 19.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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0 Area under the plasma concentration time curve over the steady state dosing intervalCmax-ss: Maximum concentration over the steady state dosing intervalTimepoint: Day 5, venous blood samples (3 mL) will be collected at 0.083, 0.25, 0.50, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 18.00 and 24.00 (Day 6) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cminss Minimum concentration over the steady state dosing interval Cavgss Average concentration over the steady state dosing interval Percentage fluctuation maxss Cminss Cavgss 100 Tmax ss Time of maximum measured plasma concentration over the steady state dosing interval Swing Cmax ss Cmin ss Cmin ss Cpd pre-dose concentration Pre dose concentrations determined before a dose at steady stateTimepoint: Venous blood samples 3 mL will be withdrawn within 5 minutes prior to dosing on Day 3 4 5 to confirm steady-state condition On Day 5 venous blood samples 3 mL will be collected at 0083 025 050 100 133 167 200 during drug infusion 233 267 300 350 400 500 600 800 1000 1200 1800 and 2400 Day 6 hours after the start of the infusion Post dose samples will be collected with allowed window period of 3 minutes | — |
Countries
Bangladesh, India
Contacts
Public ContactDrSubhraLahiri
AXIS Clinicals Ltd
Outcome results
None listed