Overview

A Study to Investigate Pharmacokinetic Drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin

Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
0
Participant gender:
Male
Summary
This is a phase 1, open label, two-cohort, single-sequence, crossover study
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Yuhan Corporation
Treatments:
Amlodipine
Rosuvastatin Calcium
Telmisartan
Telmisartan amlodipine combination
Criteria
Inclusion Criteria:

- Healthy male with body mass index(BMI) between 18.5 and 28 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 due to
reasons including laboratory test results, ECGs, or vital signs

- Sitting blood pressure meeting the following criteria at screening: 160 ≥ systolic
blood pressure ≤100 (mmHg) and 95 ≥ diastolic blood pressure ≤ 60 (mmHg)