Hypertension
Conditions
Keywords
Hypertension, CKD-828, Telmisartan, S-amlodipine, Pharmacokinetic
Brief summary
A randomized, open-label, single-dose, four-period, two-way, crossover study,
Detailed description
A randomized, open-label, single-dose, four-period, two-way, crossover study to compare the pharmacokinetics and safety CKD-828 (Fixed Dose Combination Tablet) to coadministration telmisartan and s-amlodipine in health volunteers.
Interventions
DRUGCKD-828
Telmisartan 80mg /S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily (1arm:2period and 4period, 2arm:1period and 3period)
DRUGTelmisartan
\- Telmisartan 80mg tablet, Oral, Once Daily (Combination Therapy with S-amlodipine) (1arm:1period and 3period, 2arm: 2period and 4period)
DRUGS-amlodipine
\- S-amlodipine 5mg tablet, Oral, Once Daily (combination Therapy with Telmisartan) (1arm:1period and 3period, 2arm: 2period and 4period)
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 No maximum
Healthy volunteers
Yes
Inclusion criteria
* A healthy volunteer over 20 years old * More than 50kg and within 20% of ideal body weight * No any congenital or chronic diseases and medical symptom * Appropriate for the study from examination(laboratory test, ECG etc.) within 4weeks prior to the first IP administration * Signed the informed consent form prior to the study participation.
Exclusion criteria
* History of relevant hypersensitivity against drug * Clinical significant disease or medical history (ex. hepato/cholangio, cardio, endo, hemato, onco, CNS etc.) * Active liver disease or abnormal laboratory result (AST or ALT or Total bilirubin \> 1.5\*ULN) * SBP \<90mmHg or SBP \>150mmHg * DBP \<50mmHg or DBP \>100mmHg * Creatinine clearance \<80mL/min * A Disease(ex.inflammatory intestinal disease, gastric or duodenal ulcer ,hepatic disease history , gastro-intestinal surgery except for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug * The evidence of severe attack or acute disease or surgical intervention within 28 days prior to the first IP administration. * A drug abuse or a heavy caffeine consumer (more than 5 cups per a day) or regular alcohol consumer(more than 21 units/week) or a heavy smoker(more than 10 cigarettes per a day) * Taking ETC medicine or oriental medicine within 14days or Taking OTC medicine within 7days prior to the first IP administration * Abnormal diet(Especially, grapefruit juice within 7 days prior to the first IP administration) that may influence on the absorption, distribution, metabolism and excretion of the drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. | up to 144 hours post dose |
| AUClast after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. | up to 144 hours post dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. | up to 144 hours post dose | — |
| t1/2 after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. | up to 144 hours post dose | — |
| AUCinf after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. | up to 144 hours post dose | — |
| Number of participants with adverse events | up to 59days post dose | \- Adverse Event monitoring |
Countries
South Korea
Outcome results
None listed