Bioequivalent study for a generic product of fluconazole capsule 50 mg

An open-label, randomized, single dose, crossover pivotal bioequivalence study of fluconazole capsule 50 mg in healthy adult subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0003344

Enrollment

Registered

2018-11-13

Start date

2019-02-01

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Sinlge oral administration of reference products (old-line manufacturing fluconazole capsule 50 mg) under fasting conditions and single oral dose of test products (new-line manufacturing flucon

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy male or female subjects between 19 and 55 years. 2. No clinically relevant abnormailities identified by blood pressure, pulse rate, 12-lead ECG, physical examination, and laboratory tests. 3. Femail subjects without evidences of pregnancy. 4. Body mass index of 17.5 to 30.5 kg/m2; and a total body weight over 50 kg. 5. A personally signed and dated informed consentt document indicating that the subject has been informed of all pertinent aspects of the trial. 6. Subjects who are willing and able to comply with scheduled visits, treatemtn plan, laboratory tests, and other trial procedures.

Exclusion criteria

Exclusion criteria: 1. Present illnesses or histories of clinically significant diseases. 2. Any gastrointestinal disorders affecting drug absorption. 3. A positive urine durg screen. 4. Regular alcohol consumption exceeding 21 units/week (14 units/week for females) within 6 months of screening. 5. Treatment with an investigational drug within 3 months or 5 half-lives (whichever is longer) prior to the first dose of trial medications. 6. Systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90mmHg. 7. QTc interval > 450 msec or QRS interval > 120 msec in 12-lead ECG. 8. AST or ALT >= 2 ULN, or total bilirunin >= 2.0 mg/mL. 9. Female subjects of childbearing potential or male subjects who are not willing to use appropriate contraception during the study and for at least 28 days which is longer after the final study drug administration. Femail subjects who are possibly pregnant or breastfeeding. 10. Use of prescription or nonprescription drugs, dietary supplements within 7 days or 5 half-lives (which is longer) prior to the first dose of trial medications. 11. Use of CYP inducers or inhibitors within 1 month of screening. (Herbal supplements must be discontinued before 28 days prior to the first dose of trail meidations.) 12. Blood donations over 1 pint (500 mL) within 60 days prior to dosing. (except plasmapheresis) 13. History of sensitivity to heparin or heparin-induced thromnocytopenia. 14. Any positive result of HBsAg, anti-HCV, anti-HIV, HIV ag, and RPR. 15. Subject unwilling or unable to comply with the lifestyle guidelines. 16. Employees or their family of trial sites, bioanalytical laboratories, contract research organizations, and sponsors. 17. Subjects whose medical or psychologic status considered ineligible by investigators, suicidal intent or suicide attemps. 18. Sensitivity to investigational products, ingredients, or azole derivatives. 19. Galactose intolerance, Lapp lactose deficiency, or glucose-galactose malansorption.

Design outcomes

Primary

Measure	Time frame
Area under concentration-time curve;Maximum plasma concentration	—

Secondary

Measure	Time frame
Area under concentration-time curve to infinity;Time to maximum plasma concentration;Terminal half-life	—

Countries

Korea, Republic of

Contacts

Public ContactJaeWoo Kim

Chungnam National University Hospital

zeusy@cnuh.co.kr+82-42-280-6941

Outcome results