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Fluconazole

Generic Name
Fluconazole
Brand Names
Diflucan
Drug Type
Small Molecule
Chemical Formula
C13H12F2N6O
CAS Number
86386-73-4
Unique Ingredient Identifier
8VZV102JFY
Background

Fluconazole, commonly known as Diflucan, is an antifungal drug used for the treatment of both systemic and superficial fungal infections in a variety of tissues. It was initially approved by the FDA in 1990. This drug is an azole antifungal, in the same drug family as ketoconazole and itraconazole. Fluconazole has many advantages over the other antifungal drugs including the option of oral administration. The side effect profile of this drug is minimal. It has been demonstrated as an efficacious treatment for vaginal yeast infections in one single dose.

Indication

Fluconazole can be administered in the treatment of the following fungal infections:

1) Vaginal yeast infections caused by Candida

2) Systemic Candida infections

3) Both esophageal and oropharyngeal candidiasis

4) Cryptococcal meningitis

5) UTI (urinary tract infection) by Candida

6) Peritonitis (inflammation of the peritoneum) caused by Candida

A note on fungal infection prophylaxis

Patients receiving bone marrow transplantation who are treated with cytotoxic chemotherapy and/or radiation therapy may be predisposed to candida infections, and may receive fluconazole as prophylactic therapy.

A note on laboratory testing

Obtaining specimens for fungal culture and other important laboratory studies such as serology or pathology is advised before starting fluconazole therapy in order to isolate the organisms to be eliminated through treatment. It is permissible to start therapy before the results are available, however, adjusting the therapy once laboratory results confirm the causative organism may be necessary.

Associated Conditions
Candida intertrigo, Candida pneumonia, Candida urinary tract infection, Candidemia, Candidiasis, Coccidioidomycosis, Esophageal Candidiasis, Fungal Infections, Fungal peritonitis caused by Candida, Meningitis, Cryptococcal, Oropharyngeal Candidiasis, Peritoneal candidiasis, Pneumonia cryptococcal, Pruritus, Skin Irritation, Systemic Candida Infections caused by Candida, Vaginal Candidiasis, Disseminated Candidiasis

Bioequivalence (BE) Study Comparing Fluconazole 150mg Capsule Manufactured in China and in France

First Posted Date
2018-08-08
Last Posted Date
2021-07-16
Lead Sponsor
Pfizer
Target Recruit Count
36
Registration Number
NCT03621072
Locations
🇨🇳

Wuxi People's Hospital//Phase One Unit, Wuxi, Jiangsu, China

Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers

Phase 1
Completed
Conditions
NASH - Nonalcoholic Steatohepatitis
Interventions
First Posted Date
2018-08-01
Last Posted Date
2018-12-05
Lead Sponsor
Enanta Pharmaceuticals, Inc
Target Recruit Count
48
Registration Number
NCT03610945
Locations
🇺🇸

Pharmaceutical Research Associates, Inc.,, Salt Lake City, Utah, United States

Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease

First Posted Date
2018-03-26
Last Posted Date
2022-02-09
Lead Sponsor
Children's Hospital of Philadelphia
Target Recruit Count
10
Registration Number
NCT03476317
Locations
🇺🇸

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
First Posted Date
2018-03-01
Last Posted Date
2018-09-06
Lead Sponsor
Eisai Inc.
Target Recruit Count
50
Registration Number
NCT03451110
Locations
🇺🇸

Worldwide Clinical Trials, San Antonio, Texas, United States

Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis

Phase 2
Completed
Conditions
Candida Vulvovaginitis
Interventions
First Posted Date
2017-08-17
Last Posted Date
2021-08-12
Lead Sponsor
Scynexis, Inc.
Target Recruit Count
186
Registration Number
NCT03253094
Locations
🇺🇸

Drexel University, Philadelphia, Pennsylvania, United States

🇺🇸

Wake Research Associates, LLC, Raleigh, North Carolina, United States

🇺🇸

New Age Medical Research Corp., Miami, Florida, United States

and more 21 locations

Zinc as Enhancer in Immune Recovery After Stem Cell Transplantation for Hematological Malignancies

First Posted Date
2017-05-19
Last Posted Date
2020-01-07
Lead Sponsor
Azienda Ospedaliero, Universitaria Pisana
Target Recruit Count
20
Registration Number
NCT03159845
Locations
🇮🇹

Hematology UO, Pisa, Italy

A Study to Evaluate the Effect of Fluconazole and Itraconazole on Erdafitinib Pharmacokinetics in Healthy Adult Participants

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2017-05-01
Last Posted Date
2025-02-03
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
54
Registration Number
NCT03135106
Locations
🇧🇪

Clinical Pharmacology Unit, Merksem, Belgium

Treatment With Tamoxifen in Cryptococcal Meningitis

Phase 2
Completed
Conditions
Meningitis
Meningitis Streptococcal
Meningoencephalitis
Hiv
Interventions
First Posted Date
2017-04-13
Last Posted Date
2019-12-02
Lead Sponsor
Oxford University Clinical Research Unit, Vietnam
Target Recruit Count
50
Registration Number
NCT03112031
Locations
🇻🇳

Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam

🇻🇳

Cho Ray Hospital, Ho Chi Minh City, Vietnam

🇻🇳

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

Safety and Pharmacokinetics of Oral F901318 (Fluconazole and Posaconazole) IN Aml Leukaemia

First Posted Date
2017-01-30
Last Posted Date
2018-02-15
Lead Sponsor
F2G Biotech GmbH
Registration Number
NCT03036046

Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize Effects of a Moderate CYP3A Inhibitor on PK of Tazemetostat, Effects of Tazemetostat on PK of CYP2C8 and CYP2C19 Substrates, and Effect of Increased Gastric pH on PK of Tazemetostat in B-cell Lymphoma or Advanced Solid Tumor Patients

Phase 1
Completed
Conditions
Diffuse Large B Cell Lymphoma
Primary Mediastinal Lymphoma
Mantle Cell Lymphoma
Advanced Solid Tumor
Marginal Zone Lymphoma
Interventions
First Posted Date
2017-01-23
Last Posted Date
2023-06-26
Lead Sponsor
Epizyme, Inc.
Target Recruit Count
32
Registration Number
NCT03028103
Locations
🇺🇸

Columbia University Medical Center, New York, New York, United States

🇺🇸

University of Arizona Cancer Center, Tucson, Arizona, United States

🇺🇸

Moffitt Cancer Center, Tampa, Florida, United States

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