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This study was conducted to compare the rate and extent of absorption of valsartan and hydrochlorothiazide. To maximize the possibility of finding drug-drug interactions, the dose of valsartan and hydrochlorothiazide was doubled (320 mg of VAL and 25 mg of HCT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valsartan 320 mg alone | Other | Valsartan alone |
|
| Hydrochlorothiazide 25 mg alone | Other | Hydrochlorothiazide alone |
|
| Valsartan 320 mg + Hydrochlorothiazide 25 mg | Other | Concomitant administration of valsartan 320 mg + Hydrochlorothiazide 25 mg |
|
| Valsartan / Hydrochlorothiazide 320 mg/25mg | Other | Fixed dose combination of valsartan 320 mg + Hydrochlorothiazide 25 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valsartan/Hydrochlorothiazide | Drug | Co-administration or fixed dose combination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability | Tolerability was assessed based on changes in vital signs (temperature, blood pressure, pulse, and heart rate), measured before dosing in each period and approximately every 4 hours thereafter, and laboratory tests (hematology, biochemistry, liver function, and urinalysis), and performed at baseline and at the end of the study. In addition, a physician questioned volunteers about any adverse events occurring during the study, addressed them as necessary, and recorded them on the appropriate form. This physician was not blinded to treatment, but had no involvement in the study. | Participants will be followed for the duration of study, an expected average of 6 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Valsartan | Drug | Valsartan alone |
|
| Hydrochlorothiazide | Drug | Hydrochlorothiazide alone |
|
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |