Comparison of the safety and pharmacokinetics of UI014 and UIC201616 under fedconditions in healthy volunteers

A randomized, open-label, single-dosing, 2x2 crossover study to compare the safety and pharmacokinetics of UI014 tablet with UIC201606 under fed conditions in healthy male volunteers.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0003304

Enrollment

Registered

2018-10-31

Start date

2018-09-17

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 (UIC201606 capsule 135 mg) under fed conditions and single oral dose of test products (UI014 tablet 110 mg) under fed conditions 2 weeks later.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Healthy male, between 19-45 of age. 2. Total body weight is at least 55 kg and within 20% of ideal body weight. 3. No morbid conditions or findings under medical examinations. No congenital disorders or chronic diseases. 4. Abnormal laboratody tests judged clinically significant. 5. Volunteers should read, sign, and date an informed consent form priort to any study procedures.

Exclusion criteria

Exclusion criteria: 1. Clinically significant present illnesses or past histories. 2. Gastrointestinal disorders affecting the absorption of investigational drugs. 3. Allergic reations to any ingredient of investigation products or allgergic reactions to derivatives. 4. Galactose intolerance, Lapp lactose deficiency, or glucose-galactose malansorption. 5. Systolic blood pressure >= 140 mmHg,< 90 mmHg, or diastolic blood pressure >= 95 mmHg, <60 mmHg, or pulse rate >= 100 bpm. 6. Impared hepatic function or gallbladder disorders. 7. Impared renal function. 8. Alanine aminotransferase is equal to or more than 100 IU/L. 9. Creatinine clearance is less than 30 mL/min. 10. Drug abuse. 11. CYP inducers or inhinitors like barbital within 1 month prior to the administration of investigational products. 12. Heavy drinkings within 1 month prior to the administration of investigational products. 13. Taking prescription medications or herbal herbal medicines within 2 weeks prior to the administration of investigational products. 14. Taking OTC drugs or OTC vitamins within 10 days prior to the administration of investigational products. 15. Using any investigationa drug within 3 months prior to the administration of investigational products. 16. Whole blood donation within 2 months prior to the administration of investigational products. 17. Apheresis within 1 month prior to the administration of investigational products. 18. alcohol abuse over 21 units per week. 19. Subjects unwilling or unable to comply with the alcohol restriction during the hospitalization. 20. smoking over 10 cigarettes per day within recent 3 months. 21. Subjects considered ineligible by investigators. 22. Unable to use appropriate contraception during the study.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Area under the time-concentration curve to infinite;Time to maximum concentration;terminal half-life;Apparent clearance	—

Countries

Korea, Republic of

Contacts

Public ContactJaeWoo Kim

Chungnam National University Hospital

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

Outcome results