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Pharmacology, ClinicalPhase 1OrcaNCT03929861

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

A Phase 1 study testing Fluconazole (BAYT006267) 150 mg capsules and Fluconazole 150 mg capsules (DiflucanTM) in people with Pharmacology, Clinical, run by Bayer at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Pharmacology, Clinical
What is being tested?
Fluconazole (BAYT006267) 150 mg capsules and Fluconazole 150 mg capsules (DiflucanTM)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteGermany
Study dates
31 Jul 2012to 10 Sep 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Study site

    Mannheim, Baden-Wurttemberg, 68167

Other trials in Germany

About this study

Official title: An Open-label, Randomized, Two-treatment, Two-period, Two-sequence, Cross-over, Mono-center Bioequivalence Study to Compare Single Doses of Fluconazole 150 mg Capsule (Test Product) With Diflucan™ Capsule 150 mg (Reference) in Healthy Volunteers

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

Read the detailed description

Clinical pharmacology

Being tested
Fluconazole (BAYT006267) 150 mg capsules, Fluconazole 150 mg capsules (DiflucanTM)
Keywords
Fluconazole, bioequivalence, capsule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluconazole (BAYT006267) 150 mg capsulesDrug

    Fluconazole 150 mg

  • Fluconazole 150 mg capsules (DiflucanTM)Drug

    Fluconazole 150 mg

Study groups in NCT03929861
Study groupRoleWhat they receive
Fluconazole, period 1ExperimentalSubjects 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
Receives: Drug: Fluconazole (BAYT006267) 150 mg capsules; Drug: Fluconazole 150 mg capsules (DiflucanTM)
Fluconazole, period 2ExperimentalSubjects 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
Receives: Drug: Fluconazole (BAYT006267) 150 mg capsules; Drug: Fluconazole 150 mg capsules (DiflucanTM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

    Concentration maximum

    Measured: Pre-dose and up to 72 hours post-dose

  2. AUC0-tlast

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

    Measured: Pre-dose and up to 72 hours post-dose

Secondary outcomes (4)

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

    Measured: Up to 7 weeks

  2. tmax

    Time of maximum concentration

    Measured: Pre-dose and up to 72 hours post-dose

  3. t½λz

    Half-life associated with the terminal slope

    Measured: Pre-dose and up to 72 hours post-dose

  4. MRT

    Mean residence time

    Measured: Pre-dose and up to 72 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2019
  2. Study start31 Jul 2012
  3. Primary completion10 Sep 2012
  4. Study completion10 Sep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03929861
Sponsor's protocol ID
16165
Other IDs
2011-006159-13
Acronym
Orca
Status last verified
Apr 2019
First submitted
17 Apr 2019
Last updated
29 Apr 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fluconazole (BAYT006267) 150 mg capsules and Fluconazole 150 mg capsules (DiflucanTM) in people with Pharmacology, Clinical, run by Bayer at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: Pre-dose and up to 72 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03929861.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.

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