A Drug Interaction Study of SLM0807 and HKB0701 in Healthy Subjects

NCT01039896 | Completed Phase 1

• 1 other identifier: CJ_VCM_101
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Css,max and AUCinf

  up to 24hrs

Secondary Outcomes (1)

• AUCtau, AUCt, Tmax

  up to 24hrs

Study Arms (2)

Group1

EXPERIMENTAL

SLM0807

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

Group2

EXPERIMENTAL

SLM0807 and HKB0701

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

Interventions

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

Group1

Period I : HKB0710 and SLM0807, Period II : SLM0807 DRUG

Group2

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

Related Publications (1)

• Kim HS, Oh M, Kim EJ, Song GS, Ghim JL, Shon JH, Kim DH, Shin JG. Effect of voglibose on the pharmacokinetics of metformin in healthy Korean subjects. Int J Clin Pharmacol Ther. 2014 Nov;52(11):1005-11. doi: 10.5414/CP202160.

  PMID: 25161160 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jae Gook Shin, MD, ph D

  Inje University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 25, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: February 13, 2013

Record last verified: 2013-02