Status:
COMPLETED
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
Lead Sponsor:
In-Jin Jang, MD, PhD
Collaborating Sponsors:
Oita University
Seoul National University Hospital
Conditions:
Healthy
Eligibility:
All Genders
20-50 years
Phase:
PHASE4
Brief 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 o...
Eligibility Criteria
Inclusion
- 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
- A subject with history of allergies including study drug (acebutolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01514019
Start Date
January 1 2012
End Date
May 1 2012
Last Update
June 20 2012
Active Locations (2)
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1
General Clinical Research Center, Oita University Hospital
Ōita, Japan
2
Seoul National University Hospital
Seoul, South Korea