Type 2 Diabetes Mellitus
Conditions
Keywords
Drug-Drug interaction between the CKD-501 and ketoconazole
Brief summary
The purpose of this study is to assess the effect of Ketoconazole on the pharmacokinetic characteristics of CKD-501 in healthy subject.
Detailed description
From day 1 to day 5, Ketoconazole 200mg is administered twice daily to Group 1 patients during period 1. Then on day 5,CKD-501 0.5mg is co-administered Group 1 patients at period 1. After 28 day-break, period 2 will CKD-501 0.5mg administered on day 5. Period 2 will not Ketoconazole administered. Group 2 is administered in reverse order.
Interventions
DRUGCKD-501, Ketoconazole
Subjects received single 0.5mg doses of CKD-501 alone in one period and, in the other period, Ketoconazole 200 mg twice daily for 5 day with the CKD-501 dose also co-administered with Ketoconazole on day 5.
Sponsors
Severance Hospital
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Between 20 aged and 45 years old in healthy males * 18.5 ≤ IBW \< 25 * Agreement with written informed consent
Exclusion criteria
* Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of party * Medication with drug-mediated induction/inhibition metabolic enzyme such as Midazolam within 1 month or with may affect the clinical trial * Subject has taken abnormal meals which affects the ADME of drug * Subject has a history(such as gastric or duodenal ulcer, gastrointestinal surgical histories except for an appendectomy) affects the ADME of drug * Substance abuse, or a history of drug abuse showed a positive for the party * Continued to be taking caffeine (caffeine \> 5 cup/day), drinking (alcohol \> 210 g/week) or cannot stop drinking or severe heavy smoker(cigarette \> 10 cigarettes per day)during clinical trials * Previously participated in other trial within 60 days * Previously donate whole blood within 60 days or component blood within 30 days * Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug * SBP \>140 mmHg, SBP \< 90 mmHg or DBP \> 90 mmHg, DBP \< 50 mmHg or Pulse \> 100 per/min, Pulse \< 50 per/min * 12-lead ECG, QTc \> 450 msec * An impossible one who participates in clinical trial by investigator's decision including laboratory test result
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CKD-501 AUC | 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr |
Secondary
| Measure | Time frame |
|---|---|
| CKD-501 Cmax | 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr |
| CKD-501 Tmax | 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr |
Countries
South Korea
Outcome results
None listed