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| Name | Class |
|---|---|
| Oita University | OTHER |
| Seoul National University Hospital | OTHER |
| Kyushu University | OTHER |
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An open-label, single-dose, two-treatment, randomized, cross-over study to investigate the effects of the SLCO2B1 c.1457C>T polymorphism and apple juice on the pharmacokinetics and pharmacodynamics of acebutolol in healthy Korean and Japanese volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acebutolol | Experimental | Acebutolol 200 mg capsule (Acetanol®) |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acebutolol | Drug | Acebutolol |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC of acebutolol 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. | 0-24 hr after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure of the subjects who administered acebutolol according to the SLCO2B1 genotypes | Blood pressure (systolic, diastolic) measurement will be presented as descriptive statistics for the difference from baseline where appropriate. | 0-24 hr after drug admnistration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyoichi Ohashi, MD, PhD | Department of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine, Oita, Japan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Clinical Research Center, Oita University Hospital | ÅŒita | Japan | ||||
| Seoul National University Hospital |
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| Placebo | Drug | Placebo capsule(Capsules filled up with lactose) |
|
|
| Seoul |
| South Korea |
| ID | Term |
|---|---|
| D000070 | Acebutolol |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
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