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
Overview
- Phase
- Phase 4
- Intervention
- Acebutolol
- Conditions
- Healthy
- Sponsor
- In-Jin Jang, MD, PhD
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- AUC of acebutolol according to the SLCO2B1 genotypes
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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 of acebutolol in healthy Korean and Japanese volunteers
Investigators
In-Jin Jang, MD, PhD
Professor of Clinical Pharmacology and Therapeutics
Seoul National University Hospital
Eligibility 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
Arms & Interventions
Acebutolol
Acebutolol 200 mg capsule (Acetanol®)
Intervention: Acebutolol
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
AUC of acebutolol according to the SLCO2B1 genotypes
Time Frame: 0-24 hr after drug administration
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.
Secondary Outcomes
- Blood pressure of the subjects who administered acebutolol according to the SLCO2B1 genotypes(0-24 hr after drug admnistration)