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BioequivalencePhase 1NCT03821480

Diflucan Bioequivalence Study For Transferring The Manufacture

A Phase 1 study testing Test drug and Reference drug in people with Bioequivalence, run by Pfizer at 1 site in South Korea.

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

This study is to assess the bioequivalence between fluconazole 50mg capsules from two different manufacturers. This is a open-label, randomized, single dose, 2-treatment, 2-period crossover study in healthy Korean male and female subjects aged 19-55, to assess the bioequivalence after taking study drugs. Read more about this study

Who is it for?
Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Bioequivalence
What is being tested?
Test drug and Reference drug
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteSouth Korea
Study dates
28 Jan 2019to 6 Mar 2019
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 19 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male and subjects who are between the ages of 19 and 55 years.
  • Female subjects who are found not to be pregnant in physical examinations
  • BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  • Subjects who are willing and able to comply with all study procedures.

Who cannot join

  • Evidence or history of clinically significant disease
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug test.
  • History of regular alcohol consumption exceeding standard for the study
  • Treatment with an investigational drug within 3 months or 5 half-lives preceding the first dose of investigational product (whichever is longer).
  • Screening seated BP 140 mm Hg (systolic) or 90 mm Hg (diastolic) and over
Show all 20Show fewer
  • Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval over 450 msec or a QRS interval over 120 msec.
  • Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, when assessed by the study-specific laboratory and confirmed by a single repeat test:
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level over 2 upper limit of normal (ULN); Total bilirubin level 2.0 mg/mL and over; subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is same or under ULN.
  • Pregnant female subjects, breastfeeding female subjects, male subjects, who are fertile enough and female subjects of childbearing potential for at least 28 days after the last dose of investigational product.
  • Use of prescription or nonprescription drugs and dietary supplements within 10 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
  • Use of any drugs known to significantly induce (e.g., barbiturates) or inhibit drug- metabolizing enzymes or excessive alcohol consumption within one month prior to the time of screening.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • History of hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV), human immunodeficiency virus (HIV) antigen or antibody, and/or syphilis (RPR, Rapid Plasma Reagin test).
  • Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of this protocol.
  • Subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
  • Other acute or chronic medical or psychiatric condition
  • Subjects with known sensitivity to the drug or any of the insert ingredients or to related azole compounds.
  • Subjects with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Chungnam National University Hospital, Clinical Trials Center

    Daejeon, 35015

Other trials in South Korea

About this study

Official title: AN OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER PIVOTAL BIOEQUIVALENCE STUDY OF FLUCONAZOLE CAPSULE 50 MG IN HEALTHY ADULT SUBJECTS

This study is to assess the bioequivalence between fluconazole 50mg capsules from two different manufacturers. This is a open-label, randomized, single dose, 2-treatment, 2-period crossover study in healthy Korean male and female subjects aged 19-55, to assess the bioequivalence after taking study drugs.

Read the detailed description

Twenty-eight (28) healthy subjects will be enrolled into the study. Screening evaluation will occur within 28 days prior to the first dose of study medication.

Subjects will be randomized to the following treatments:

  • Treatment A: Fluconazole capsule, 1 x 50 mg, Diflucan, West Ryde (REFERENCE)
  • Treatment B: Fluconazole capsule, 1 x 50 mg, Diflucan, Amboise (TEST)
Conditions
Bioequivalence
Being tested
Test drug, Reference drug
Keywords
Fluconazole

What participants receive

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

  • Test drugDrug

    Also called Fluconazole capsule 50mg

    Fluconazole capsule 50 mg Manufacturer: West Ryde

  • Reference drugDrug

    Also called Fluconazole capsule 50mg

    Fluconazole capsule 50 mg Manufacturer: Amboise

Study groups in NCT03821480
Study groupRoleWhat they receive
Fluconazole 50 mg, Manufacturer: AmboiseExperimentalTest drug
Receives: Drug: Test drug
Fluconazole 50mg, Manufacturer:West RydeActive comparatorReference drug
Receives: Drug: Reference drug

What is being measured

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

  1. 1.Area Under Curve [AUC]last of fluconazole in Whole blood

    Area Under Curve(AUC) will be evaluated with Winnonlin analysis(Linear trapezoidal linear interpolation).

    Measured: At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.

  2. 2.Maximum Plasma Concentration [Cmax] of fluconazole in Whole blood

    Plasma concentrations of fluconazole will be assayed by a validated LC- MS/MS method.

    Measured: At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.

Secondary outcomes (4)

  1. 1.AUCinf

    Area under the plasma concentration-time profile from time zero extrapolated to infinite time

    Measured: At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.

  2. 2.AUCt/AUCinf

    AUCt: Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast) AUCinf: Area under the plasma concentration-time profile from time zero extrapolated to infinite time

    Measured: At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.

  3. 3.t½

    Half-life time of fluconazole

    Measured: At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.

  4. 4.Tmax

    Time of Max concentration of fluconazole

    Measured: At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.

Timeline

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

  1. First posted29 Jan 2019
  2. Study start28 Jan 2019
  3. Primary completion6 Mar 2019
  4. Study completion6 Mar 2019

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
open-label, randomized, single dose, 2-treatment, 2-period crossover study
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03821480
Sponsor's protocol ID
A0561026
Status last verified
Jul 2021
First submitted
28 Jan 2019
Last updated
16 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Test drug and Reference drug in people with Bioequivalence, run by Pfizer at 1 site in South Korea.

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 20 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 16 Jul 2021. 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 South Korea. 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?

1.Area Under Curve [AUC]last of fluconazole in Whole blood (time frame: At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.). 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 NCT03821480.

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 16 Jul 2021.

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