Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hanmi Pharmaceutical co., ltd. | OTHER |
Not provided
Not provided
Not provided
Not provided
This clinical trial aims to assess the pharmacokinetic interaction between amlodipine and losartan in healthy male subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amlodipine, losartan, and amlodipine plus losartan | Experimental | Period 1: amlodipine 10mg will be administered orally once a day for 9 days. Period 2: losartan 100mg will be administered orally once a day for 9 days after 13 days of the washout period. Period 3: amlodipine 10mg once a day plus losartan 100mg once a day will be administered orally for 9 days after 6 days of the washout period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine10mg | Drug | Amlodipine 10mg will be administered orally twice a day for 9 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state) | 0 (predose) ~ 24 hours at day 9, day 31, and day 46 | |
| Cmax,ss(Maximum plasma concentration of the drug at steady state) | 0 (predose) ~ 24 hours at day 9, day 31, and day 46 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmin,ss(Minimum concentration of the drug in plasma at steady state) | 0 (predose) ~ 24 hours at day 9, day 31, and day 46 | |
| Tmax,ss(Time to maximum plasma concentration at steady state) | 0 (predose) ~ 24 hours at day 9, day 31, and day 46 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine | Seoul | 136-705 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019808 | Losartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
an open-label, three-period, fixed-sequence clinical trial
Not provided
Not provided
Not provided
Not provided
| Losartan potassium 100mg | Drug | Losartan 100mg will be administered orally once a day for 9 days |
|
| Amlodipine plus Losartan | Drug | Amlodipine plus Losartan same way as "arm: amlodipine" and "arm: losartan" |
|
| 1/2(Terminal elimination half-life) | 0 (predose) ~ 24 hours at day 9, day 31, and day 46 |
| CLss/F(Apparent total body clearance of the drug from plasma at steady state) | 0 (predose) ~ 24 hours at day 9, day 31, and day 46 |
| Vd,ss/F(Apparent volume of distribution at steady state) | 0 (predose) ~ 24 hours at day 9, day 31, and day 46 |
| PTF(Peak-to-trough fluctuation) | 0 (predose) ~ 24 hours at day 9, day 31, and day 46 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |