Dyslipidemia & Hypertension Clinical Trial
Official title:
A Randomized, Open-label, Single-dose, 2-way Cross-over Study to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Telmisartan and Rosuvastatin and YH16410 in Healthy Volunteers
| Verified date | October 2013 |
| Source | Yuhan Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | South Korea: Ministry of Food and Drug Safety |
| Study type | Interventional |
This is a 2 by 2 cross-over study to evaluate pharmacokinetics of telmisartan and
rosuvastatin FDC compared to reference telmisartan and rosuvastatin coadministered in two
groups enrolling healthy adult male and female subjects under fasting conditions.
Subjects will be admitted to the clinic in the evening before Day 1. All subjects will
receive a single oral dose of telmisartan/rosuvastatin FDC or telmisartan and rosuvastatin
co-administered in the morning on Day 1. All the subjects will remain in the clinical unit
until completion of all assessments on Day 2 including collection post-dose PK sample.
Subjects will return to the clinic for pharmacokinetic samples at scheduled time.
The two treatment periods will be separated by a washout period.
| Status | Completed |
| Enrollment | 185 |
| Est. completion date | September 2013 |
| Est. primary completion date | August 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 20 Years to 50 Years |
| Eligibility |
Inclusion Criteria: 1. Healthy male and female aged 20 to 50 with a body mass index(BMI) between 18.5 and 25 kg/m2 2. Acceptable medical history, physical examination, laboratory tests and EKG, during screening 3. Provision of signed written informed consent 20~50 yrs old, healthy Korean Subjects Exclusion Criteria: 1. History of and clinically significant disease 2. Sitting blood pressure meeting the following criteria at screening: 150 = systolic blood pressure =100 (mmHg) and 100 = diastolic blood pressure = 65 (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 28 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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Severance Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yuhan Corporation |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | plasma pharmacokinetic parameters for telmisartan and rosuvastatin in relevant treatments | 0~72hr, 17points | No |