A Drug Interaction Study of SLM0807 and HKB0701 in Healthy Subjects

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

CJ Cheiljedang Corporation

ClinicalTrials.gov Identifier:

NCT01039896

First received: December 23, 2009

Last updated: February 11, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 23, 2009

Last Updated Date

February 11, 2013

Start Date ^ICMJE

June 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Css,max and AUCinf [ Time Frame: up to 24hrs ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01039896 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

AUCtau, AUCt, Tmax [ Time Frame: up to 24hrs ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

To assess the safety and tolerability of concomitant administration of HKB0701 and SLM0807 [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Drug Interaction Study of SLM0807 and HKB0701 in Healthy Subjects

Official Title ^ICMJE

An Open-label, Randomized, Crossover Study to Evaluate the Safety and Pharmacokinetics After Multiple Administration of SLM0807 Alone and Multiple Co-administration of HKB0701/SLM0807 in Korean Healthy Subjects

Brief Summary

The aim of this study is to assess whether HKB0701 alters pharmacokinetics of SLM0807.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Diabetes Mellitus

Intervention ^ICMJE

Drug: Period I : SLM0807, Period II : HKB0701 and SLM0807
Drug: Period I : HKB0710 and SLM0807, Period II : SLM0807

Study Arm (s)

Experimental: Group1
SLM0807

Intervention: Drug: Period I : SLM0807, Period II : HKB0701 and SLM0807
Experimental: Group2
SLM0807 and HKB0701

Intervention: Drug: Period I : HKB0710 and SLM0807, Period II : SLM0807

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 or alcohol abuse (caffeine drink >5cups /day, alcohol >30g/day)
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 (cimetidine within 7days prior to drug administration)
Female subjects who are pregnant, breastfeeding or not using medically acceptable birth control

Gender

Both

Ages

20 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01039896

Other Study ID Numbers ^ICMJE

CJ_VCM_101

Has Data Monitoring Committee

Responsible Party

CJ Cheiljedang Corporation

Study Sponsor ^ICMJE

CJ Cheiljedang Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jae Gook Shin, MD, ph D

Inje University

Information Provided By

CJ Cheiljedang Corporation

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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