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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
Study Summary
This study is evaluating whether a drug used to treat fungal infections is as effective as the brand name drug.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bio availability
Side effects data
From 2014 Phase 2 trial • 55 Patients • NCT0189133114%
Vaginitis Bacterial
7%
Dermatitis Contact
7%
Trichamoniasis
7%
Nausea
7%
Ear Infection
7%
Oropharyngeal Pain
7%
Upper Respiratory Tract Infection
7%
Conjunctivitis Bacterial
7%
Nasopharyngitis
7%
Sinusitits
7%
Urinary Tract Infection
7%
Dyspareunia
7%
Metrorrhagia
7%
Urticaria
7%
Pain in Extremity
100%
80%
60%
40%
20%
0%
Study treatment Arm
VT-1161 300mg QD
VT-1161 600mg QD
VT-1161 600mg BID
Fluconazole 150mg
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: FlucanazoleExperimental Treatment1 Intervention
The Objective of This Study Was an Open-label, Randomized, 2-way Crossover to Compare the Single-dose Relative Bioavailability of Flucanazole 40mgm/ml 35 ml Suspension and to measure AUC at 0, 1 , 4 , 8, 12, 16 , 20 and 24 hours Under Fed Condition
Group II: DiflucanActive Control1 Intervention
The Objective of This Study Was an Open-label, Randomized, 2-way Crossover to Compare the Single-dose Relative Bioavailability of Diflucan 40mgm/ml 35 ml Suspension and to measure AUC at 0, 1 , 4 , 8, 12, 16 , 20 and 24 hours Under Fed Condition
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Who is running the clinical trial?
Sutphin DrugsLead Sponsor
3 Previous Clinical Trials
5,504 Total Patients Enrolled
Frequently Asked Questions
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