Albendazole is an orally administered broad-spectrum anthelmintic Drug used in treatment of human alveolar and cystic echinococcosis. To date, data on albendazole and tissue pharmacokinetics are limited. The aim of the present study is to measure albendazole levels in plasma, cystic tissue and fluid by ex-vivo microdialysis following concurrent therapy with albendazole prior scheduled surgery. This will contribute to a more complete understanding of the drug’s penetration to its site of action.
Conditions
Interventions
Trade Name: Eskazole
Pharmaceutical Form: Tablet
INN or Proposed INN: Albendazole oxide
CAS Number: 54029-12-8
Other descriptive name: Ricobendazole
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Medical University Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cohort A only: - Confirmed Cystic Echinococcosis based on WHO criteria Cohort B only: - Confirmed Alveolar Echinococcosis based on WHO criteria Both cohorts: - Male or Female, Age above 18 years - Weight: > 60kg - Indication for cystectomy - Indication for therapy with albendazole prior to surgery - Active stages only (CE 2-3, WHO Informal Working Group on Echinococcosis standardized ultrasound classification of echinococcal cysts) - A signed and dated written informed consent form - The subject can understand and willing to comply with protocol requirements and timetables, instructions and protocol-stated restrictions Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: • < 18 years of age • Patients not willing to participate in the study • Contraindication against albendazole or any ingredient • Positive serology in Screening (Virology) • Severe bleeding disorder • Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To obtain pharmacokinetic data of albendazole in plasma, cystic tissue and intra-cystic fluid of echinococcus cysts after the administration of albendazole prior to surgery;Secondary Objective: •Pharmacokinetic (PK) calculations and comparison to currently discussed breakpoints •Collection of safety data of albendazole;Primary end point(s): - penetration ratio calculated as tissue concentration (Ct) divided by plasma concentration - area under the concentration time curve (AUC) from zero to last observed concentration (AUC0-t), AUC from zero to infinity (AUC0-8), maximum drug concentration (Cmax), half-life (t1/2), time to reach maximum drug concentration (tmax) in plasma ;Timepoint(s) of evaluation of this end point: end of study day and final examination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): collection of adverse events during study participation ;Timepoint(s) of evaluation of this end point: end of study day and final examination | — |
Countries
Austria
Contacts
Public ContactDepartment of Clinical Pharmacology
Medical University Vienna
Outcome results
None listed