Single Dose Crossover Comparative Bioavailability Study of Two Formulations of Fluconazole 200 mg in Healthy Adult Subjects Under Fasting Conditions

• Status: Unknown status
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This single dose study is designed in accordance with EMA (the European Medicines Agency) regulatory guidelines, with the aim of characterizing the comparative bioavailability of fluconazole in the two formulations in healthy subjects. As this is a bioequivalence trial where each subject will receive each study treatment in a crossover fashion, a control group is not included. Within the clinical portion of the study each subject will receive a single oral dose of the test and the reference formulation in compliance with the generated randomization code. The primary study endpoints are the pharmacokinetic (PK) parameters Cmax and AUC0-t of fluconazole.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pharmtechnology LLC
• Collaborators: Altasciences Company Inc.; Altasciences Company, Inc.
• Treatments: Fluconazole

Criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form (ICF)

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Healthy Caucasian adult male or female

4. If female, meets one of the following criteria:

1. Is of childbearing potential and agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first study drug administration through to at least 30 days after the last dose of the study drug. An acceptable method of contraception includes one of the following:

• Abstinence from heterosexual intercourse

• Systemic contraceptives (combined birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)

• Intrauterine device (with or without hormones)

• Male condom with spermicide or male condom with a vaginal spermicide (gel, foam, or suppository)

• Male partner vasectomized at least 6 months prior to the first study drug administration

Or

2. Male partner has had a vasectomy less than 6 months prior to dosing, and agrees to use an additional acceptable contraceptive method from the first study drug administration through to at least 30 days after the last dose of the study drug

Or

3. Is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or is in a postmenopausal state (i.e. at least 1 year without menses without an alternative medical condition prior to the first study drug administration)

5. Aged at least 18 years but not older than 55 years

6. Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively

7. Non- or ex-smoker (An ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration)

8. Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without clinical significance, as determined by an investigator

9. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator

Exclusion Criteria:

1. Female who is lactating at screening

2. Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration

3. History of significant hypersensitivity to fluconazole, any related azole compounds, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs

4. Presence or history of significant gastrointestinal, liver or kidney disease, or any other condition that is known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects

5. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease

6. Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment

7. Seated blood pressure below 110/60 mmHg at the screening visit

8. History of rare hereditary problems of galactose and/or lactose intolerance, lactase deficiency or glucose-galactose malabsorption

9. Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)

10. Any clinically significant illness in the 28 days prior to the first study drug administration

11. Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of an investigator would put into question the status of the participant as healthy

12. Any history of tuberculosis

13. Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration

14. Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests

15. Inclusion in a previous group for this clinical study

16. Intake of fluconazole in the 28 days prior to the first study drug administration

17. Use of terfenadine, astemizole, erythromycin, quinidine, pimozide, or cisapride in the 7 days prior to the first study drug administration

18. Intake of an Investigational Product (IP) in the 28 days prior to the first study drug administration

19. Donation of 50 mL or more of blood in the 28 days prior to the first study drug administration

20. Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the 56 days prior to the first study drug administration