check_circleStudy Completed
Pharmacology, Clinical
Bayer Identifier:
16165
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
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
MaleAge
18 - 50 YearsTrial summary
Enrollment Goal
26Trial Dates
July 2012 - September 2012Phase
Phase 1Could I Receive a placebo
NoProducts
Fluconazole (BAYT006267)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Mannheim, 68167, Germany |
Primary Outcome
- CmaxConcentration maximumdate_rangeTime Frame:Pre-dose and up to 72 hours post-doseenhanced_encryptionNoSafety Issue:
- AUC0-tlastArea under the plasma concentration time curve from time 0 to the last data point above the lower limit of quantificationdate_rangeTime Frame:Pre-dose and up to 72 hours post-doseenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of participants with Adverse Events as a Measure of safety and tolerabilitydate_rangeTime Frame:Up to 7 weeksenhanced_encryptionYesSafety Issue:
- tmaxTime of maximum concentrationdate_rangeTime Frame:Pre-dose and up to 72 hours post-doseenhanced_encryptionNoSafety Issue:
- t½λzHalf-life associated with the terminal slopedate_rangeTime Frame:Pre-dose and up to 72 hours post-doseenhanced_encryptionNoSafety Issue:
- MRTMean residence timedate_rangeTime Frame:Pre-dose and up to 72 hours post-doseenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2Additional Information
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