check_circleStudy Completed

Pharmacology, Clinical

Bioequivalence trial to prove equal blood concentrations of two different Fluconazole formulations

Trial purpose

Primary Objective: To compare the bioavailability of a single dose of fluconazole 150 mg capsules (Test product) with the bioavailability of a single dose of Diflucan™ capsules, 150 mg (Reference) administered under fasting conditions in order to assess bioequivalence
Secondary Objectives: To assess safety and tolerability in form of adverse events and clinical parameters (systolic/diastolic blood pressure, pulse rate, body temperature, physical examination, electrocardiogram, clinical laboratory testing, and overall tolerability) and to assess further pharmacokinetic parameters of fluconazole

Key Participants Requirements

Sex

Male

Age

18 - 50 Years

Trial summary

Enrollment Goal
26
Trial Dates
July 2012 - September 2012
Phase
Phase 1
Could I Receive a placebo
No
Products
Fluconazole (BAYT006267)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Mannheim, 68167, Germany

Primary Outcome

  • Cmax
    Concentration maximum
    date_rangeTime Frame:
    Pre-dose and up to 72 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC0-tlast
    Area under the plasma concentration time curve from time 0 to the last data point above the lower limit of quantification
    date_rangeTime Frame:
    Pre-dose and up to 72 hours post-dose
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of participants with Adverse Events as a Measure of safety and tolerability
    date_rangeTime Frame:
    Up to 7 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • tmax
    Time of maximum concentration
    date_rangeTime Frame:
    Pre-dose and up to 72 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • t½λz
    Half-life associated with the terminal slope
    date_rangeTime Frame:
    Pre-dose and up to 72 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • MRT
    Mean residence time
    date_rangeTime Frame:
    Pre-dose and up to 72 hours post-dose
    enhanced_encryption
    Safety Issue:
    No

Trial design

An open-label, randomized, two-treatment, two-period, two-sequence, cross-over, mono-center bioequivalence study to compare single doses of Fluconazole 150 mg capsule (test product) with Diflucan™ capsule 150 mg (reference) in healthy volunteers
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
2