Diabetes Mellitus
Conditions
Brief summary
The objective of this study is to demonstrate the bioequivalence of CJ30001(fixed-dose combination tablet of HKB0701 and SLM0807) relative to HKB0701 and SLM0807 co-administered to healthy subjects.
Interventions
DRUGPeriod I : HKB0701 and SLM0807, Period II : CJ30001
DRUGPeriod I : CJ30001, Period II : HKB0701 and 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 50 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean Cmax | up to 24hrs |
| Geometric mean AUCt | up to 24hrs |
Outcome results
None listed