Diabetes Mellitus
Conditions
Brief summary
The aim of this study is to assess whether HKB0701 alters pharmacokinetics of SLM0807.
Interventions
DRUGPeriod I : SLM0807, Period II : HKB0701 and SLM0807
DRUGPeriod I : HKB0710 and SLM0807, Period II : SLM0807
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Css,max and AUCinf | up to 24hrs |
Secondary
| Measure | Time frame |
|---|---|
| AUCtau, AUCt, Tmax | up to 24hrs |
Outcome results
None listed