Bioequivalence study of Liposomal Amphotericin B 50 mg/vial of Bharat Serums and Vaccines Ltd.
Not Applicable
Completed
- Registration Number
- CTRI/2023/05/052602
- Lead Sponsor
- Bharat Serums and Vaccines Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Healthy male volunteers
Subject who can give written informed consent and communicate effectively
Exclusion Criteria
History of any major surgical procedure
History of any clinically significant medical conditions.
History of chronic alcoholism/ chronic smoking/ drug of abuse.
Subjects with known hypersensitivity to Liposomal Amphotericin B or any of the excipients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the pharmacokinetic profile of Test formulation in comparison to the Reference productTimepoint: PK samples will be collected predose, post dose every hour till 8 hours then every 2 hours till 14 hours. then 4 hourly till 24 hours, then daily till day 7
- Secondary Outcome Measures
Name Time Method Safety and tolerability of liposomal amphotericin bTimepoint: Post dose AEs will be captured till the end of study