BE Study of the Combinations of Gemigliptin 50mg and Rosu... | NCT02670070

Studies
BE Study of the Combinations of Gemigliptin 50mg and Rosuvastatin 20mg in Comparison to Each Component Administered Alone

NCT02670070

Sponsor

LG Life Sciences

Status

Unknown status

Last Update Posted

May 11, 2016Estimated

Enrollment

37Actual

Phase

Phase 1

Conditions

Healthy

Interventions

gemigliptin 50mg, rosuvastatin 20mg

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

Official Title

A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics, Safety, and Tolerability of the Combination of Gemigliptin/Rosuvastatin 50/20 mg in Comparison to Each Component Gemigliptin 50 mg and Rosuvastatin 20 mg Administered in Healthy Male Volunteers

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Apr 2016Actual

Completion Date

Jun 2016Estimated

First Submitted Date

Dec 22, 2015

First Submission Date that Met QC Criteria

Jan 27, 2016

First Posted Date

Feb 1, 2016Estimated

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

May 10, 2016

Last Update Posted Date

May 11, 2016Estimated

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

This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.

Detailed Description

This study is to evaluate the safety/tolerability and pharmacokinetics(AUC and Cmax) of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.

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

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Coadministration of G+R	Active Comparator	Coadministration of gemigliptin 50mg and rosuvastatin 20mg	Drug: gemigliptin 50mg, rosuvastatin 20mg
Combination G/R	Experimental	Combination of gemigliptin 50mg / rosuvastatin 20mg	Drug: gemigliptin 50mg, rosuvastatin 20mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gemigliptin 50mg, rosuvastatin 20mg	Drug	gemigliptin/rosuvastatin 50/20mg	Coadministration of G+R Combination G/R

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUClast, Cmax	To evaluate AUClast/Cmax of gemigliptin and rosuvastatin	up to 72h post-dose

Secondary Outcomes

Measure	Description	Time Frame
AUCinf	To evaluate AUCinf of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin	up to 72h post-dose
Tmax	To evaluate Tmax of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 19 to 45, healthy male subjects(at screening)
BMI between 18.0 - 27.0
FPG 70-125mg/dL glucose level(at screening)
Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
Subject who already participated in other trials in 2months
Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently.
Heavy smokers.(>10 cigarettes per day)

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 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
Kyung Sang Yu, MD, PhD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C534891	LC15-0444
D000068718	Rosuvastatin Calcium

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes

Browse Leaves

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Browse Branches

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