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

NCT ID: NCT03929861

Last Updated: 2019-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2012-09-10

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

Detailed Description

Clinical pharmacology

Conditions

Pharmacology, Clinical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Fluconazole, period 1

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

Group Type: EXPERIMENTAL

Fluconazole (BAYT006267) 150 mg capsules

Intervention Type: DRUG

Fluconazole 150 mg

Fluconazole 150 mg capsules (DiflucanTM)

Intervention Type: DRUG

Fluconazole 150 mg

Fluconazole, period 2

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

Group Type: EXPERIMENTAL

Fluconazole (BAYT006267) 150 mg capsules

Intervention Type: DRUG

Fluconazole 150 mg

Fluconazole 150 mg capsules (DiflucanTM)

Intervention Type: DRUG

Fluconazole 150 mg

Interventions

Fluconazole (BAYT006267) 150 mg capsules

Fluconazole 150 mg

Intervention Type: DRUG

Fluconazole 150 mg capsules (DiflucanTM)

Fluconazole 150 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Subjects with QTc intervals of more than 450 ms calculated by Bazett's formula
• Subjects with a pulse rate below 50 or above 90 beats per minute
• Subjects with serum creatinine concentrations outside the range of <1.20 mg/dL
• Subjects with a medical disorder, condition or history of such that could impair the subject's ability to participate or complete this trial in the opinion of the Investigator
• Participated in the treatment phase of another clinical trial within 30 days prior to first administration of the IMP
• Blood donation or blood sample collection exceeding 200 mL within the last 30 days
• Unwilling or unable to comply with all requirements outlined in the protocol
• Excessive sports or sauna within 5 days before start of the treatment phase
• Consumption of xanthine- and quinine-containing food and beverages and certain fruit juices such as grapefruit juice within 72 h before IMP administration
• Alcohol consumption within 24 h before screening and within 72 h before IMP administration (on Day -1 verified by alcohol breath test)
• History of alcohol or drug abuse within the last 5 years
• History of smoking (within the last 12 months before screening)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Mannheim, Baden-Wurttemberg, Germany

Countries

Germany

Related Links

http://www.clinicaltrialsregister.eu/

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

Other Identifiers

2011-006159-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16165

Identifier Type: -

Identifier Source: org_study_id