Phase 1 Clinical trial to investigate the Effect of Food on the Pharmacokinetics of YH14755 compared to Co-administration of Rosuvastatin and Metformin SR in Healthy Volunteers
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0001116
- Lead Sponsor
- Yuhan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 56
1. Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2
2. Who has not suffered from clinically significant disease
3. Provision of signed written informed consent
1.History of and clinically significant disease
2. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
3. Administration of other investigational products within 3 months prior to the first dosing.
4. Administration of herbal medicine within 4 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
5. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUClast of rosuvastatin and metformin ;Cmax of rosuvastatin and metformin
- Secondary Outcome Measures
Name Time Method Tmax of rosuvastatin and metformin ;t1/2 of rosuvastatin and metformin ;%AUC of rosuvastatin and metformin ;AUCinf of rosuvastatin and metformin