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
Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Acebutolol (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: In-Jin Jang, MD, PhD Official(s) and/or principal investigator(s): Kyoichi Ohashi, MD, PhD, Study Chair, Affiliation: Department of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine, Oita, Japan
Summary
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
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: AUC of acebutolol according to the SLCO2B1 genotypes
Secondary outcome: Blood pressure of the subjects who administered acebutolol according to the SLCO2B1 genotypes
Eligibility
Minimum age: 20 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subject is informed of the investigational nature of this study and voluntarily
agrees to participate in this study and signs an Institutional Review Board (IRB) -
approved informed consent prior to performing any of the screening procedures
Exclusion Criteria:
- A subject with history of allergies including study drug (acebutolol) or other drug
allergies (aspirin, antibiotics, etc.), or history of clinically significant
allergies
Locations and Contacts
General Clinical Research Center, Oita University Hospital, Oita, Japan
Seoul National University Hospital, Seoul, Korea, Republic of
Additional Information
Starting date: January 2012
Last updated: June 19, 2012
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