Type 2 Diabetes Mellitus
Conditions
Keywords
Drug-Drug interaction between the CKD-501 and Amlodipine
Brief summary
The purpose of this study is to assess the pharmacokinetic drug interaction between CKD-501 and amlodipine after oral administration in healthy male volunteers.
Detailed description
Volunteers doses three times over the period of CKD-501 0.5mg or Amlodipine 10mg alone/co-administrate, repeated doses are 10 days.
Interventions
DRUGCKD-501
Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.
DRUGamlodiopine
Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.
DRUGCKD-501 amlodipine
Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.
Sponsors
Severance Hospital
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 * Body weight ≥ 55kg and 18.5 ≤ IBW \< 25 * Agreement with written informed consent
Exclusion criteria
* Subject has a history affects the ADME of drug * Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of party * Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) * AST,ALT \> UNL \* 1.25 or Total bilirubin \> UNL \* 1.5 * Estimated GFR(MDRD) \< 80 * SBP \>150 mmHg, SBP \< 100 mmHg or DBP \> 100 mmHg, DBP \< 60 mmHg or Pulse \> 100 per/min, Pulse \< 50 per/min * 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 * Medication with drug-mediated induction/inhibition metabolic enzyme within 30 days or with may affect the clinical trial * Medication within 2 weeks in the first professional medical, medicine, OTC, vitamins taking * Subject takes grapefruit within 1 month * Previously participated in other trial within 60 days * Previously donate whole blood within 60 days or component blood within 30 days * 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 | Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24hr |
| Amlodipine AUC | Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 48, 72hr |
Secondary
| Measure | Time frame |
|---|---|
| CKD-5011 Tmax | Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24hr |
| Amlodipine Tmax | Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 48, 72hr |
Countries
South Korea
Outcome results
None listed