Anidulafungin pharmacokinetics given as a single intravenous dose to obese patients (ADOPT).
Phase 4
Completed
- Conditions
- Candidiasis / Fungal infections10017528
- Registration Number
- NL-OMON40398
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
Inclusion Criteria
1. Patient has a BMI >=40 kg/m2 and is undergoing bariatric surgery.
2. Subject is at least 18 years of age on the day of screening.
3. If subject is female: neither pregnant, nor able to become pregnant and is not nursing an infant.
4. Subject or legal representatives are able and willing to sign the Informed Consent before screening evaluations.
Exclusion Criteria
1. Documented history of sensitivity to medicinal products or excipients similar to those found in the anidulafungin preparation.
2. History of or current abuse of drugs, alcohol or solvents.
3. Inability to understand the nature of the trial and the procedures required.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measurement will be the area under the plasma concentration-<br /><br>time curve (AUC) from time 0 to infinity (inf) post infusion (AUC0- inf) value<br /><br>of anidulafungin. This will be determined by use of the log-linear trapezoidal<br /><br>rule.<br /><br>Peak plasma concentrations (Cmax) will be directly observed from the data.<br /><br>The elimination rate constant will be determined by linear regression of the<br /><br>terminal points of the log-linear plasma concentration time curve. Clearance<br /><br>(CL) will be calculated as dose/AUC0- inf. </p><br>
- Secondary Outcome Measures
Name Time Method <p>N/A</p><br>