Study with Liposomal Amphotericin B in Healthy Volunteers to compare the blood concentration of the Test product with marketed product
Not Applicable
- Registration Number
- CTRI/2024/01/062043
- Lead Sponsor
- Bharat Serums and Vaccines Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
BMI 18.5 to 29.9 kg per m2 and weight more than 50 kg
Healthy volunteers
Normal or clinical insignificant biochemical heamtological urine and serology parameters
normal or clinical insignificant ECG
Negative urine test for drugs of abuse alcohol breath analysis
willing to use contraception
willing to give informed consent and communicate effectively
Exclusion Criteria
history of surgical procedures in past
history of clinical significant cardiac gastric renal endocrine neurological metabolic psychiatric hematological disorders
history of chronic alcoholism chronic smoking drug of abuse
hypersensitivity to liposomal amphotericin b or its excipients
history of consumption of tobacco containing products
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method