Diflucan Bioequivalence Study For Transferring The Manufacture
NCT03821480
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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
- 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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Changchun, Jilin
- Daejeon,
- Wuxi, Jiangsu
Descriptive Information | |||||
---|---|---|---|---|---|
Brief Title ICMJE | Diflucan Bioequivalence Study For Transferring The Manufacture | ||||
Official Title ICMJE | AN OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER PIVOTAL BIOEQUIVALENCE STUDY OF FLUCONAZOLE CAPSULE 50 MG IN HEALTHY ADULT SUBJECTS | ||||
Brief 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. | ||||
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:
| ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: open-label, randomized, single dose, 2-treatment, 2-period crossover study Masking: None (Open Label)Primary Purpose: Basic Science | ||||
Condition ICMJE | Bioequivalence | ||||
Intervention ICMJE |
| ||||
Study Arms ICMJE |
| ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE | 28 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | March 6, 2019 | ||||
Actual Primary Completion Date | March 6, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
| ||||
Sex/Gender ICMJE |
| ||||
Ages ICMJE | 19 Years to 55 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Korea, Republic of | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03821480 | ||||
Other Study ID Numbers ICMJE | A0561026 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
| ||||
IPD Sharing Statement ICMJE |
| ||||
Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | ||||
Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
| ||||
PRS Account | Pfizer | ||||
Verification Date | December 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |