Bioequivalence Trial to Prove Equal Blood Concentrations of Two Different Fluconazole Formulations

NCT03929861 | Completed Phase 1

• 2 other identifiers: 161652011-006159-13
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pharmacology, Clinical

Keywords

Fluconazole; bioequivalence; capsule

Outcome Measures

Primary Outcomes (2)

• Cmax

  Concentration maximum

  Pre-dose and up to 72 hours post-dose

• AUC0-tlast

  Area under the plasma concentration time curve from time 0 to the last data point above the lower limit of quantification

  Pre-dose and up to 72 hours post-dose

Secondary Outcomes (4)

• Number of participants with Adverse Events as a Measure of safety and tolerability

  Up to 7 weeks

• tmax

  Pre-dose and up to 72 hours post-dose

• t½λz

  Pre-dose and up to 72 hours post-dose

• MRT

  Pre-dose and up to 72 hours post-dose

Study Arms (2)

Fluconazole, period 1

EXPERIMENTAL

Subjects were randomized to receive a single dose of 150 mg fluconazole on Day 1 of period 1 after an overnight fast of at least 10 hours

Drug: Fluconazole (BAYT006267) 150 mg capsules; Drug: Fluconazole 150 mg capsules (DiflucanTM)

Fluconazole, period 2

EXPERIMENTAL

Subjects were randomized to receive a single dose of 150 mg fluconazole on Day 1 of period 2 after an overnight fast of at least 10 hours

Drug: Fluconazole (BAYT006267) 150 mg capsules; Drug: Fluconazole 150 mg capsules (DiflucanTM)

Interventions

Fluconazole (BAYT006267) 150 mg capsules DRUG

Fluconazole 150 mg

Fluconazole, period 1; Fluconazole, period 2

Fluconazole 150 mg capsules (DiflucanTM) DRUG

Fluconazole 150 mg

Fluconazole, period 1; Fluconazole, period 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males in the age between 18 and 50 years
• Subjects with a body weight of at least 50 kg and a BMI between 18.5 and 30.0 kg/m2
• Subjects had to be willing to use an acceptable method of contraception (double barrier) during the study and 2 weeks after the end of the study
• All subjects had to give their written informed consent prior to admission to the trial
• Legal capacity and subject ability to understand the nature, scope and risk/benefit of the trial

You may not qualify if:

• Any finding of physical examination (including blood pressure, pulse rate, and ECG) deviating from normal and of clinical relevance
• Positive test for hepatitis B surface antigen test, anti hepatitis C virus (anti-HCV), or human immunodeficiency virus (HIV)-1/2 antibodies and HIV-1 p24-antigen
• Positive drug screen test (verified by "Mahsan-Kombi/DOA2" and "Kombi 4/O2TSchnelltest"), or any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine, opiates, and cannabis abuse
• More than moderate alcohol consumption (\>40 g of alcohol regularly per day)
• Demonstrated excess in xanthine consumption (more than 5 cups of coffee or equivalent per day)
• Subjects with known hypersensitivity to fluconazole and any other excipient of the test products and subjects with lactose intolerance
• Subjects with known hypersensitivity to other azoles
• Any need of medication during the trial except allowed medication (paracetamol up to 1 g a day)
• Any concomitant medication, including herbal remedies, within 10 days before administration of the investigational medicinal product (IMP), or within a period shorter than 10 times the elimination half-life of the respective medication
• History of severe allergies, non-allergic drug reactions, multiple drug allergies or active hay fever
• Any active disease, acute or chronic
• Febrile or infectious illness within 1 week before screening
• Any other disease or condition which could influence the metabolism of the drug (e.g., endocrine diseases)
• Any gastrointestinal complaints within 1 week before screening (gastrointestinal disorders including irritable bowel and gastrointestinal ulcer)
• Any relevant history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal (especially history of chronic gastritis or peptic ulcers), neurological (especially history of epileptic seizures), endocrinological, immunological, psychiatric or cardiovascular disease, myopathies and bleeding disorders

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

MeSH Terms

Interventions

Fluconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 29, 2019
• Study Start: July 31, 2012
• Primary Completion: September 10, 2012
• Study Completion: September 10, 2012
• Last Updated: April 29, 2019

Record last verified: 2019-04

Locations

DE (1)