A randomized, open-label, single-dose, four-period, two-way, crossover study,
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Telmisartan 80mg /S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily (1arm:2period and 4period, 2arm:1period and 3period)
\- Telmisartan 80mg tablet, Oral, Once Daily (Combination Therapy with S-amlodipine) (1arm:1period and 3period, 2arm: 2period and 4period)
\- S-amlodipine 5mg tablet, Oral, Once Daily (combination Therapy with Telmisartan) (1arm:1period and 3period, 2arm: 2period and 4period)
Kyungpook National University Hospital
Daegu, Samdeok-dong, 2-ga 50, Samdeok-dong, 2-ga 50 Jung-gu, South Korea
Cmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
Time frame: 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.
Time frame: up to 144 hours post dose
Tmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
Time frame: 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.
Time frame: 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.
Time frame: up to 144 hours post dose
Number of participants with adverse events
\- Adverse Event monitoring
Time frame: up to 59days post dose
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