A Phase 1 Clinical Trial to Investigate Pharmacokinetics and Drug Interaction of Rosuvastatin and Telmisartan in Healthy Volunteers
- Conditions
- Not Applicable
- Registration Number
- KCT0000584
- Lead Sponsor
- Yuhan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 48
1. Healthy male and female aged 20 to 50 with a body mass index(BMI) between 19 and 27 kg/m2
2. Acceptable medical history, physical examination, laboratory tests and EKG, during screening
3. Provision of signed written informed consent
1.History of and clinically significant disease
2.Sitting blood pressure meeting the following criteria at screening:
150 = systolic blood pressure =90 (mmHg) and
95 = diastolic blood pressure = 50 (mmHg) amd
100 = Heart rate = 40
3. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
4. Administration of other investigational products within 90 days prior to the first dosing.
5. Administration of herbal medicine within 30 days or administration of ethical drugs within 14 days or administration of over-the-counter (OTC) drugs within 7 days 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).
6.Have AST(SGOT) or/and ALT(SGPT) > 3 times of normal upper limit at the time of screening
7. 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 Part 1: AUCt,ss, Cmax,ss of rosuvastatin ;Part 2: AUCt,ss,Cmax,ss of telmisartan
- Secondary Outcome Measures
Name Time Method Part 1: AUClast,ss, AUCinf,ss, Tmax,ss, t1/2, Cmin,ss of rosuvastatin and AUC?,ss, Cmax,ss, AUClast,ss, AUCinf,ss, Tmax,ss, t1/2, Cmin,ss of N-desmetyl rosuvastatin;Part 2: AUClast,ss, AUCinf,ss, Tmax,ss, t1/2, Cmin,ss of telmisartan