Overview

Study of Multiple Oral Dosing to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
Summary
A non-randomized, two-arm, single-sequence, crossover, open label, multiple oral dosing clinical trial to evaluate the safety and the pharmacokinetic drug-drug interaction of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Daewon Pharmaceutical Co., Ltd.
Treatments:
Amlodipine
Rosuvastatin Calcium
Telmisartan
Criteria
Inclusion Criteria:

- Healthy male who are ≥19, <50 years old

- Man who weights over 55kg and whose BMI is 18~30(kg/m2)

- Man who doesn't have any chronic disease or history of disease

Exclusion Criteria:

- man who has or had any clinically relevant disease of liver, kidney,
nervous/respiratory/musculoskeletal/cardiovascular/hemato-oncology system or
neuropsychiatry