Clinical Trial to Evaluate the Effect on the Pharmacokine... | NCT01548157

Studies
Clinical Trial to Evaluate the Effect on the Pharmacokinetic Characteristics of HCP1007 Capsule

NCT01548157

Sponsor

Hanmi Pharmaceutical Company Limited

Status

Completed

Last Update Posted

Jun 4, 2013Estimated

Enrollment

28Actual

Phase

Phase 1

Conditions

Healthy

Interventions

HCP1007 / omarco and crestor

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 2013

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

Mar 2012

Primary Completion Date

Mar 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Feb 27, 2012

First Submission Date that Met QC Criteria

Mar 5, 2012

First Posted Date

Mar 8, 2012Estimated

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

Jun 3, 2013

Last Update Posted Date

Jun 4, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 pharmacokinetics and safety after oral administration of HCP1007 capsules and Rosuvastatin plus Omega-3.

Detailed Description

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1007 capsules and Rosuvastatin plus Omega-3.

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

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HCP1007	Experimental	HCP1007	Drug: HCP1007 / omarco and crestor
omarco and crestor	Active Comparator	Rosuvastatin plus Omega-3	Drug: HCP1007 / omarco and crestor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HCP1007 / omarco and crestor	Drug	HCP1007 / Rosuvastatin plus Omega-3	HCP1007 omarco and crestor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under Curve(AUC) last		0,0.5,1,1.5,2,2.5,3,4,5,6,9,12,24,48hours post-dose

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male volunteers, age between 20 and 45
Informed of the investigational nature of this study and voluntarily agree to participate in this study
BMI of >20kg/m2 and <26kg/m2 subject

Exclusion Criteria:

Use of any prescription medication within 14 days prior to Day 1
Use of any medication within 7 days prior to Day 1
Participation in another clinical study within 60 days prior to start of study drug administration

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
kyun seop Bae, MD, Ph.D	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul			South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D000068718	Rosuvastatin Calcium

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes

Browse Leaves

Not provided

Browse Branches

Not provided