Dyslipidemias, Hypertension
Conditions
Brief summary
The object of clinical trial is to investigate the pharmacokinetics and safety compared to CKD-333 and co-administration CKD-330, D090 under fasting condition in healthy male adults.
Detailed description
An open-label, randomized, fasted, single-dose, three-way crossover study to compare the pharmacokinetic characteristics and safety between administration of CKD-333 and coadministration of CKD-330 and D090 in healthy male adults
Interventions
DRUGCKD-333, formula I
Test drug
DRUGCKD-333, formula II
Test drug
DRUGCKD-330, D090
Reference Drug
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male adults aged 19 to 45 years 2. Body weight more than 50kg and within ideal body weight ±20% 3. signed informed consent form
Exclusion criteria
1. Have clinical significant medical history or disease that cardiovascular system, respiratory system, kidney, endocrine system, hematological system, digestive system , mental illness 2. Have a gastrointestinal disease history that can effect drug absorption or surgery 3. Systolic Blood pressure≥140mmHg or Systolic Blood pressure\<90mmHg, Diastolic Blood Pressure≥90mmHg or Diastolic Blood Pressure\<60mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUClast of Candesartan | 0 hour ~ 72 hour after drug administration | Area under the plasma concentration-time curve to last concentration of Candesartan |
| AUClast of Amlodipine | 0 hour ~ 72 hour after drug administration | Area under the plasma concentration-time curve to last concentration of Amlodipine |
| AUClast of Atorvastatin | 0 hour ~ 72 hour after drug administration | Area under the plasma concentration-time curve to last concentration of Atorvastatin |
| Cmax of Candesartan | 0 hour ~ 72 hour after drug administration | Maximum plasma concentration of Candesartan |
| Cmax of Amlodipine | 0 hour ~ 72 hour after drug administration | Maximum plasma concentration of Amlodipine |
| Cmax of Atorvastatin | 0 hour ~ 72 hour after drug administration | Maximum plasma concentration of Atorvastatin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCinf of Atorvastatin | 0 hour ~ 72 hour after drug administration | Area under the plasma concentration-time curve from zero to infinity concentration of Atorvastatin |
| Tmax of 2-hydroxy atorvastatin | 0 hour ~ 72 hour after drug administration | Time to maximum plasma concentration of 2-hydroxy atorvastatin |
| T1/2 of Candesartan | 0 hour ~ 72 hour after drug administration | Half-life of Candesartan |
| T1/2 of Amlodipine | 0 hour ~ 72 hour after drug administration | Half-life of Amlodipine |
| T1/2 of Atorvastatin | 0 hour ~ 72 hour after drug administration | Half-life of Atorvastatin |
| T1/2 of 2-hydroxy atorvastatin | 0 hour ~ 72 hour after drug administration | Half-life of 2-hydroxy atorvastatin |
| clearance of Candesartan | 0 hour ~ 72 hour after drug administration | Apparent clearance of Candesartan |
| Tmax of Candesartan | 0 hour ~ 72 hour after drug administration | Time to maximum plasma concentration of Candesartan |
| clearance of Atorvastatin | 0 hour ~ 72 hour after drug administration | Apparent clearance of Atorvastatin |
| clearance of 2-hydroxy atorvastatin | 0 hour ~ 72 hour after drug administration | Apparent clearance of 2-hydroxy atorvastatin |
| Vd/F of Candesartan | 0 hour ~ 72 hour after drug administration | Apparent volume of distribution of Candesartan |
| Vd/F of Amlodipine | 0 hour ~ 72 hour after drug administration | Apparent volume of distribution of Amlodipine |
| Vd/F of Atorvastatin | 0 hour ~ 72 hour after drug administration | Apparent volume of distribution of Atorvastatin |
| Vd/F of 2-hydroxy atorvastatin | 0 hour ~ 72 hour after drug administration | Apparent volume of distribution of 2-hydroxy atorvastatin |
| clearance of Amlodipine | 0 hour ~ 72 hour after drug administration | Apparent clearance of Amlodipine |
| Tmax of Amlodipine | 0 hour ~ 72 hour after drug administration | Time to maximum plasma concentration of Amlodipine |
| Tmax of Atorvastatin | 0 hour ~ 72 hour after drug administration | Time to maximum plasma concentration of Atorvastatin |
| AUCinf of 2-hydroxy atorvastatin | 0 hour ~ 72 hour after drug administration | Area under the plasma concentration-time curve from zero to infinity concentration of 2-hydroxy atorvastatin |
| AUCinf of Candesartan | 0 hour ~ 72 hour after drug administration | Area under the plasma concentration-time curve from zero to infinity concentration of Candesartan |
| AUCinf of Amlodipine | 0 hour ~ 72 hour after drug administration | Area under the plasma concentration-time curve from zero to infinity concentration of Amlodipine |
Countries
South Korea
Contacts
Primary ContactSeunghun Han, Ph.D.
Outcome results
None listed