Pharmacokinetic Drug Interaction Between Candesartan and... | NCT02079506

Studies
Pharmacokinetic Drug Interaction Between Candesartan and Rosuvastatin

NCT02079506

Sponsor

Alvogen Korea

Status

Completed

Last Update Posted

Mar 5, 2014Estimated

Enrollment

40Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Candesartan
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

Mar 2014

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

Feb 2014

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Mar 4, 2014

First Submission Date that Met QC Criteria

Mar 4, 2014

First Posted Date

Mar 5, 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

Mar 4, 2014

Last Update Posted Date

Mar 5, 2014Estimated

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 objective of this study is to compare pharmacokinetics after single oral administration of candesartan and rosuvastatin each separately versus coadministration of candesartan and rosuvastatin in healthy male 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

40Actual

Label	Type	Description	Intervention Names
Treatment A	Experimental		Drug: Candesartan
Treatment B	Experimental		Drug: Rosuvastatin

Name	Type	Description	Arm Group Labels	Other Names
Candesartan	Drug		Treatment A
Rosuvastatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUCτ,ss of candesartan	0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h	22 points
Cmax,ss of candesartan	0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h	22 points
AUCτ,ss of rosuvastatin	0(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h	28 points
Cmax,ss of rosuvastatin	0(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h	28 points

Secondary Outcomes

Measure	Description	Time Frame
tmax,ss of candesartan	0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h	22 points
CLss/F of candesartan	0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male volunteers af aged between 20 years to 45 years
Have a weight above 55kg and Ideal body weight (IBW) between -20% and +20% inclusive
Eligible subjects with acceptable medical history and physical examination

Exclusion Criteria:

- Have a known hypersensitivity or history of clinically significant hypersensitivity to drugs including the same class drugs with candesartan or rosuvastatin, or other drugs

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
JangHee Hong, PhD.	Chungnam National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chungnam National University Hospital		Jung-gu	Daejeon	301-721	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
C081643	candesartan
D000068718	Rosuvastatin Calcium

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes

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Browse Branches

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