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

HK inno.N

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus

Treatments

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

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01370681

CJ_VCM_102

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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