Comparison of the safety and pharmacokinetics of UI014 and UIC201616 under fedconditions in healthy volunteers
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0003304
- Lead Sponsor
- Korea United Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Male
- Target Recruitment
- 60
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.
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under the time-concentration curve;Maximum concentration
- Secondary Outcome Measures
Name Time Method Area under the time-concentration curve to infinite;Time to maximum concentration;terminal half-life;Apparent clearance