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Fluconazole

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jan 19, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

Fluconazole · 2 trials · 1 indication

Phase 1 2
NCT01511770Bioavailability Study of Fluconazole Tablets 200 mg Under Fasting ConditionsHealthy
COMPLETED17 Analytics
NCT01511757Bioavailability Study of Fluconazole Tablets 200 mg Under Fed ConditionsHealthy
COMPLETED15 Analytics
PHASE1COMPLETED
Bioavailability Study of Fluconazole Tablets 200 mg Under Fasting Conditions
Healthy
NCT0151177017
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PHASE1COMPLETED
Bioavailability Study of Fluconazole Tablets 200 mg Under Fed Conditions
Healthy
NCT0151175715
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Study Endpoints

Primary Endpoints

Area Under Curve (AUC)
pre dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5,4, 6, 9, 12, 24, 48 and 72 hours post-dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
FluconazoleEXPERIMENTALFluconazole Tablets 200 mg of Dr. Reddy's Laboratories limited.
DiflucanACTIVE_COMPARATORDiflucan 200 mg fluconazole tablets of Pfizer

Interventions

NameTypeDescription
FluconazoleDRUGFluconazole Tablets, 200 mg
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Exclusion Criteria: History or presence of significant: • cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease. In addition, history or presence of: * alcoholism or drug abuse within...

Countries:Canada
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