Pharmacokinetics and Drug Interaction Study Between Amlod... | NCT02089399

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

NCT02089399

Sponsor

Daewoong Pharmaceutical Co. LTD.

Status

Completed

Last Update Posted

Apr 29, 2015Estimated

Enrollment

32Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Sevikar(amlodipne/olmesartan)
crestor(Rosuvastatin)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Mar 14, 2014

First Submission Date that Met QC Criteria

Mar 14, 2014

First Posted Date

Mar 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2015

Last Update Posted Date

Apr 29, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment AB	Experimental	S->S+C	Drug: Sevikar(amlodipne/olmesartan) Drug: crestor(Rosuvastatin)
Treatment C	Experimental	C	Drug: crestor(Rosuvastatin)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sevikar(amlodipne/olmesartan)	Drug	Treatment AB	Treatment AB
crestor(Rosuvastatin)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung medical center		Seoul			South Korea

Intervention Browse Module

MeSH Terms

ID	Term
C437965	olmesartan
D000068718	Rosuvastatin Calcium

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes

Browse Leaves

Not provided

Browse Branches

Not provided