sever fungal infections , systemic antifungal. Antifungal antibiotics, systemically used
Conditions
Interventions
Intervention 1: Intervention group: Participants randomized to the intervention group will initially (Period 1) receive the generic drug **Alentiva®** (liposomal amphotericin B, produced by Alven Phar
Sponsors
CinnaGen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age = 18 years Body Mass Index (BMI) between 18.5 and 30 kg/m² Healthy adult volunteers with normal laboratory test results No history of acute or chronic illnesses No use of any medications other than those required by the protocol Signed written informed consent form
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding women. History of renal, liver, or cardiovascular diseases Use of medications affecting the metabolism or pharmacokinetics of amphotericin B History of allergic reactions to amphotericin B.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Reach Maximum Plasma Concentration (Tmax). Timepoint: pre-dose (0.0 hour) and at 0.5, 1.0, 1.50, 2.0 (Immediately prior to the end of infusion), 2.167, 2.33, 2.67, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0, 96.0, 144.0, 192.0, 240.0, 288.0, 384.0, 480.0, 576.0, 672.0, 840.0 and 1008.0 hours after start of infusion. Method of measurement: Examination of the concentration–time curve derived from measuring the drug concentration in plasma samples.;Drug-related adverse events. Timepoint: In this study, potential adverse events related to the investigational drug will be assessed and documented at the following time points: prior to the start of infusion in each period (initial participant status assessment), during the infusion (real-time monitoring for early signs), immediately after the end of infusion (evaluation of potential immediate reactions), during the first six hours after infusion initiation (continuous monitoring by the treatment team), ten hours after infusion initiation (re-assessment for delayed symptoms), at discharge for each period, during outpatient follow-up visits at scheduled times (according to the protocol), at the end of each period (final participant assessment before the washout phase), and 45 days after the second period (final follow-up to ensure no late-onset adverse events). Method of measurement: Adverse Events are identified and recorded through participant self-reporting, direct clinical observation by the study team, repeated physical examinations, and regular assessments of vital signs (including blood pressure, heart rate, body temperature, and overall condition) at predefined time points, as well as additional laboratory evaluations when necessary.;Maximum Plasma Concentration (Cmax). Timepoint: pre-dose (0.0 hour) and at 0.5, 1.0, 1.50, 2.0 (Immediately prior to the end of infusion), 2.167, 2.33, 2.67, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0, 96.0, 144.0, 192.0, 240.0, 288.0, 384.0, 480.0, 576.0, | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactBita Shahrami
Tehran University of Medical Sciences
Outcome results
None listed