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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

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

Page last updated: August 23, 2015

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