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
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.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label