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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Sevikar(amlodipne/olmesartan); Drug: crestor(Rosuvastatin)

• Registration Number: NCT02089399
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-14
• Study First Submitted QC: 2014-03-14
• Study First Posted: 2014-03-17
• Study Start: 2014-05
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-27
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment AB	crestor(Rosuvastatin)	S-\>S+C
Treatment AB	Sevikar(amlodipne/olmesartan)	S-\>S+C
Treatment C	crestor(Rosuvastatin)	C

Primary Outcome Measures

Name	Time	Method
AUCtau	Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
Css,max	Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment

Secondary Outcome Measures

Name	Time	Method
Tss,max	Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
Css,min	Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment

Trial Locations

Locations (1)

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of