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| ID | Type | Description | Link |
|---|---|---|---|
| Pan Asian-Atenolol-1 |
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An open-label, single-dose, three-treatment, three-period study to investigate the effect of SLCO2B1 genotype and apple juice on pharmacokinetics of atenolol after oral administration in healthy male Korean.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | SLCO2B1 wild type allele |
|
| 2 | Experimental | SLCO2B1 variant allele |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atenolol | Drug | Atenolol oral administration |
| |
| Atenolol with apple juice 1200 mL |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of atenolol according to the SLCO2B1 genotypes | The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration, as calculated by the linear/log trapezoidal method will be summarized by treatment and genotype group using descriptive statistics. | 0-48 hr after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure of the subjects who administered atenolol according to the SLCO2B1 genotypes | Blood pressure measurement will be presented as descriptive statistics for the difference from baseline where appropriate. | 0-48 hr after drug admnistration |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In-Jin Jang, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| Drug |
Atenolol oral administration with apple juice 1200 mL |
|
| Atenolol with apple juice 600 mL | Drug | Atenolol oral administration with apple juice 600 mL |
|
Number of participants with adverse event as a measure of safety and tolerability *Measure of safety and tolerability: physical examinations, ECG, Laboratory tests (including hematology, chemistry, urinalysis) - Descriptive statistics will be calculated for quantitative safety data as well as for the difference from baseline where appropriate. |
| 0-48 hr after drug admnistration |
| ID | Term |
|---|---|
| D001262 | Atenolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
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