A Pharmacokinetic Study of CJ30001 and HKB0701/SLM0807 in... | NCT01370681

Studies
A Pharmacokinetic Study of CJ30001 and HKB0701/SLM0807 in Healthy Subject

NCT01370681

Sponsor

HK inno.N Corporation

Status

Completed

Last Update Posted

Jun 10, 2011Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

Diabetes Mellitus

Interventions

Period I : HKB0701 and SLM0807, Period II : CJ30001
Period I : CJ30001, Period II : HKB0701 and SLM0807

Countries

Not provided

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

Jun 2011

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

Oct 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Jun 1, 2011

First Submission Date that Met QC Criteria

Jun 9, 2011

First Posted Date

Jun 10, 2011Estimated

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 9, 2011

Last Update Posted Date

Jun 10, 2011Estimated

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

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

30Actual

Label	Type	Description	Intervention Names
Group1	Experimental		Drug: Period I : HKB0701 and SLM0807, Period II : CJ30001
Group2	Experimental		Drug: Period I : CJ30001, Period II : HKB0701 and SLM0807

Name	Type	Description	Arm Group Labels	Other Names
Period I : HKB0701 and SLM0807, Period II : CJ30001	Drug		Group1
Period I : CJ30001, Period II : HKB0701 and SLM0807

Measure	Description	Time Frame
Geometric mean Cmax		up to 24hrs
Geometric mean AUCt		up to 24hrs

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy volunteers who are in age range of 20-50years and the weight range is not exceed ±20% of ideal weight. Ideal weight = [height -100]*0.9
Subjects with no history of any significant chronic disease
Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
Available for the entire study period
Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

Subjects who have taken any drugs to induce or inhibit hepatic enzyme activity within 30days prior to drug administration
Subjects who have symptom of an acute illness within 4 weeks prior to drug administration
Subjects with a history of clinically significant allergies including drug allergies
Subjects whose clinical laboratory test values are outside the accepted normal range(Especially,AST or ALT >1.25 times to normal range or total bilirubin > 1.5times to normal range)
Subjects with a history of drug, caffeine abuse(caffeine drink >5cups/day)
Subjects with a history of alcohol abuse(alcohol>30g/day) or who have ever drinked alcohol whinin 7days prior to drug administration
Heavy smoker ( >10cigarettes/day)
Subjects who have had a diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice)
Subjects who have donated plasma within 60days prior to drug administration
Subjects who have participated in a clinical study within 90days prior to drug administration
Subjects who have received any drugs that might confound the results of the trial in the opinion of principal investigator within 10days prior to drug administration (cimetidine within 7days prior to drug administration)
Female subjects who are pregnant, breastfeeding or not using medically acceptable birth control

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases