CLINICAL TRIALS PROFILE FOR DIFLUCAN IN SODIUM CHLORIDE 0.9%

All Clinical Trials for Diflucan In Sodium Chloride 0.9%

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00075803 ↗	Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101)	Completed	Blood and Marrow Transplant Clinical Trials Network	Phase 3	2003-11-01	The study is designed as a Phase III, randomized, double-blind, multicenter, prospective, comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients. Recipients will be stratified by center and donor type (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm in a 1:1 ratio.
NCT00075803 ↗	Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101)	Completed	National Cancer Institute (NCI)	Phase 3	2003-11-01	The study is designed as a Phase III, randomized, double-blind, multicenter, prospective, comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients. Recipients will be stratified by center and donor type (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm in a 1:1 ratio.
NCT00075803 ↗	Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	2003-11-01	The study is designed as a Phase III, randomized, double-blind, multicenter, prospective, comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients. Recipients will be stratified by center and donor type (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm in a 1:1 ratio.
NCT00075803 ↗	Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101)	Completed	National Marrow Donor Program	Phase 3	2003-11-01	The study is designed as a Phase III, randomized, double-blind, multicenter, prospective, comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients. Recipients will be stratified by center and donor type (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm in a 1:1 ratio.
NCT00075803 ↗	Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101)	Completed	Medical College of Wisconsin	Phase 3	2003-11-01	The study is designed as a Phase III, randomized, double-blind, multicenter, prospective, comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients. Recipients will be stratified by center and donor type (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm in a 1:1 ratio.

Clinical Trial Conditions for Diflucan In Sodium Chloride 0.9%

Condition Name

Condition Name for Diflucan In Sodium Chloride 0.9%
Intervention	Trials
Candidiasis	5
Fungal Infection	4
Cryptococcal Meningitis	3
Candidiasis, Vulvovaginal	3

Condition MeSH

Condition MeSH for Diflucan In Sodium Chloride 0.9%
Intervention	Trials
Candidiasis	14
Mycoses	9
Infections	5
Infection	5

Clinical Trial Locations for Diflucan In Sodium Chloride 0.9%

Trials by Country

Trials by Country for Diflucan In Sodium Chloride 0.9%
Location	Trials
United States	157
Canada	14
Brazil	5
Italy	4
Spain	4

Trials by US State

Trials by US State for Diflucan In Sodium Chloride 0.9%
Location	Trials
California	9
Florida	8
Texas	8
Pennsylvania	8
North Carolina	8

Clinical Trial Progress for Diflucan In Sodium Chloride 0.9%

Clinical Trial Phase

Clinical Trial Phase for Diflucan In Sodium Chloride 0.9%
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	11
Phase 2	4

Clinical Trial Status

Clinical Trial Status for Diflucan In Sodium Chloride 0.9%
Clinical Trial Phase	Trials
Completed	27
Not yet recruiting	4
Unknown status	3

Clinical Trial Sponsors for Diflucan In Sodium Chloride 0.9%

Sponsor Name

Sponsor Name for Diflucan In Sodium Chloride 0.9%
Sponsor	Trials
Pfizer	4
Astellas Pharma Inc	3
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for Diflucan In Sodium Chloride 0.9%
Sponsor	Trials
Other	45
Industry	25
NIH	10

Diflucan in Sodium Chloride 0.9%: Clinical Trials, Market Analysis, and Projections

Introduction

Diflucan, also known as fluconazole, is a synthetic triazole antifungal agent widely used for the treatment of various fungal infections. When administered in a sodium chloride 0.9% solution, it offers a convenient and effective intravenous option. Here, we will delve into the clinical trials, market analysis, and projections for Diflucan in Sodium Chloride 0.9%.

Clinical Trials and Efficacy

Indications and Usage

Diflucan in Sodium Chloride 0.9% is indicated for the treatment of several fungal infections, including oropharyngeal and esophageal candidiasis, cryptococcal meningitis, and systemic Candida infections such as candidemia, disseminated candidiasis, and pneumonia. It is also used for prophylaxis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy[3].

Clinical Studies

In clinical trials, Diflucan has demonstrated efficacy in treating various fungal infections. For example, in a multicenter study comparing Diflucan (200 mg/day) to amphotericin B (0.3 mg/kg/day) for the treatment of cryptococcal meningitis in patients with AIDS, Diflucan showed comparable outcomes in terms of survival and clinical response[3].

Pharmacokinetics

The pharmacokinetics of Diflucan in pediatric and adult patients have been well-studied. In pediatric patients, the clearance, half-life, and volume of distribution vary by age and dose. For instance, in children aged 9 months to 13 years, the clearance of fluconazole after a single oral dose of 2 mg/kg was 0.40 mL/min/kg, with a half-life of 25 hours[3].

Drug Interactions

Diflucan can interact with several other drugs, affecting its pharmacokinetics and efficacy. For example, concomitant administration with cimetidine can decrease fluconazole's AUC and Cmax, while rifampin can reduce fluconazole's half-life and increase its clearance. Hydrochlorothiazide can increase fluconazole's AUC and Cmax by reducing renal clearance[1].

Market Analysis

Market Growth

The global market for fluconazole and sodium chloride injection is expected to grow significantly over the next few years. This growth is driven by increasing demand for antifungal treatments due to rising fungal infections, particularly in immunocompromised patients such as those undergoing chemotherapy or with HIV/AIDS[5].

Key Manufacturers

Several pharmaceutical companies are involved in the production and distribution of Diflucan in Sodium Chloride 0.9%. The market is competitive, with major players focusing on improving formulation, dosing regimens, and distribution networks to enhance patient access and compliance.

Market Trends

The market is trending towards more targeted and personalized antifungal therapies. There is an increasing focus on prophylactic use in high-risk patient populations, such as those undergoing hematopoietic stem cell transplantation. Additionally, advancements in formulation technology are making intravenous antifungal treatments more convenient and safer for patients[5].

Projections

Market Size and Forecast

The global fluconazole and sodium chloride injection market is projected to expand substantially by 2032, driven by the increasing incidence of fungal infections and the growing need for effective antifungal treatments. The market is expected to see a compound annual growth rate (CAGR) that reflects the rising demand and advancements in healthcare infrastructure[5].

Regional Analysis

The market growth will be varied across different regions. Developed countries will continue to drive the market due to better healthcare infrastructure and higher awareness of antifungal treatments. However, emerging markets are also expected to contribute significantly as healthcare access and awareness improve in these regions.

Challenges and Opportunities

Despite the positive projections, the market faces challenges such as the development of antifungal resistance, particularly in Candida species like C. krusei, which is inherently resistant to fluconazole. Opportunities lie in the development of new formulations and dosing regimens that can overcome these resistances and improve patient outcomes[3].

Key Takeaways

• Efficacy and Indications: Diflucan in Sodium Chloride 0.9% is effective for treating various fungal infections and is indicated for prophylaxis in high-risk patients.
• Clinical Trials: Clinical studies have demonstrated the efficacy of Diflucan compared to other antifungal agents.
• Market Growth: The global market is expected to grow significantly due to increasing demand for antifungal treatments.
• Market Trends: There is a focus on personalized and prophylactic antifungal therapies, along with advancements in formulation technology.
• Projections: The market is projected to expand substantially by 2032, driven by rising demand and healthcare advancements.

FAQs

What are the common indications for Diflucan in Sodium Chloride 0.9%?

Diflucan in Sodium Chloride 0.9% is indicated for the treatment of oropharyngeal and esophageal candidiasis, cryptococcal meningitis, and systemic Candida infections. It is also used for prophylaxis in patients undergoing bone marrow transplantation[3].

How does Diflucan interact with other drugs?

Diflucan can interact with several drugs, including cimetidine, rifampin, and hydrochlorothiazide, affecting its pharmacokinetics and efficacy. For example, cimetidine can decrease fluconazole's AUC and Cmax, while rifampin can reduce its half-life and increase clearance[1].

What are the potential challenges in the market for Diflucan in Sodium Chloride 0.9%?

The market faces challenges such as the development of antifungal resistance, particularly in Candida species like C. krusei. However, opportunities lie in the development of new formulations and dosing regimens to overcome these resistances[3].

What is the projected market growth for Diflucan in Sodium Chloride 0.9%?

The global market for fluconazole and sodium chloride injection is expected to grow significantly by 2032, driven by the increasing incidence of fungal infections and the growing need for effective antifungal treatments[5].

Which regions are expected to drive the market growth for Diflucan in Sodium Chloride 0.9%?

Developed countries will continue to drive the market due to better healthcare infrastructure and higher awareness of antifungal treatments. However, emerging markets are also expected to contribute significantly as healthcare access and awareness improve in these regions[5].

Sources

1. DIFLUCAN® - accessdata.fda.gov
2. application number: anda 76-617 - CPY Document - FDA
3. DIFLUCAN® - accessdata.fda.gov
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