Clinical trial to investigate pharmacokinetics and drug interaction of Crestor and Glucodown OR SR in healthy volunteers
Not Applicable
Completed
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0000349
- Lead Sponsor
- Yuhan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
1.20~50 yrs old, healthy Korean Subjects
2.Body weight 3.No congenital, chronic disease, No current disease
4.Subjects who are diagnosed to include by medical doctor from laboratory and ECG result.
5.Subjects who agree to keep contraceptive methods during the clinical trial.
Exclusion Criteria
1. Subjects who are allergic to investigational drug.
2. Subjects who have a medical history which can affect the clinical trial.
3. Hypertension(Systolic BP = 150mmHG or Diastolic BP = 100mmHG), Hypotension(Systolic BP = 100mmHg or Diastolic BP = 65mmHg)
4. Subjects who have taken other medicine in recent 2~4 weeks.
5. Subjects who have a risk of hypoglycemia and imbalance in taking a diet.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUCtau;Css,max;Safety(Vital sign, ECG, Laboratory results, Physical exam, detectable symtoms by Doctors or subjects
- Secondary Outcome Measures
Name Time Method Tss,max;AUCss,last;AUCss,inf;Css,min