Hyperlipidemia, Hypertension
Conditions
Brief summary
This is a Randomized, open-label, single-dose, 3-treatment, 3-period, 3-sequence crossover design.
Detailed description
This is a 6 by 3 cross-over study to evaluate pharmacokinetics of YH22189 FDC compared to reference telmisartan/amlodipine and rosuvastatin co-administered in three groups enrolling healthy adult male 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 YH22189 FDC or telmisartan/amlodipine or rosuvastatin 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 three treatment periods will be separated by a washout period.
Interventions
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2 * Who has not suffered from clinically significant disease * Provision of signed written informed consent
Exclusion criteria
* History of and clinically significant disease * A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs * Administration of other investigational products within 3 months prior to the first dosing * Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs * Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 60 (mmHg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Telmisartan Cmax | 0 - 72 hrs |
| Telmisartan AUClast | 0 - 72 hrs |
| Amlodipine Cmax | 0 - 168 hrs |
| Amlodipine AUClast | 0 - 168 hrs |
| Rosuvastatin Cmax | 0 - 48 hrs |
| Rosuvastatin AUClast | 0 - 48 hrs |
Countries
South Korea
Outcome results
None listed