A Phase 4 interventional study of Atenolol and Atenolol with apple juice 1200 mL in Healthy, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-01-23.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment
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.
Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SLCO2B1 wild type allele
Drug: Atenolol · Drug: Atenolol with apple juice 1200 mL · Drug: Atenolol with apple juice 600 mL
SLCO2B1 variant allele
Drug: Atenolol · Drug: Atenolol with apple juice 1200 mL · Drug: Atenolol with apple juice 600 mL
Atenolol oral administration
Atenolol oral administration with apple juice 1200 mL
Atenolol oral administration with apple juice 600 mL
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.
Time frame: 0-48 hr after drug administration
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.
Time frame: 0-48 hr after drug admnistration
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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.
Time frame: 0-48 hr after drug admnistration
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital