Pharmacokinetics and Drug Interaction Study Between Amlodipine,Olmesartan and Rosuvastatin in Healthy Adult Volunteers

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: crestor(Rosuvastatin); Drug: Sevikar(amlodipne/olmesartan)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02089399

DW_DWJ1351001

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between amlodipine, olmesartan and rosuvastatin in healthy adult volunteers.

Enrollment: 32 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects aged 19 - 55 years
• A body mass index in the range 19 - 27 kg/m2
• Willingness to participate during the entire study period
• Written informed consent after being fully informed about the study procedures

Exclusion criteria

• Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
• History of clinically significant drug hypersensitivity
• Use of medication within 7 days before the first dose
• Heavy drinker (>140 g/week)
• Whole blood donation during 60 days before the study
• Judged not eligible for study participation by investigator

Trial design

32 participants in 2 patient groups

Treatment AB

Experimental group

Description:

S-\>S+C

Treatment:

Drug: crestor(Rosuvastatin)

Drug: Sevikar(amlodipne/olmesartan)

Treatment C

Experimental group

Description:

C

Treatment:

Drug: crestor(Rosuvastatin)