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

In-Jin Jang, MD, PhD

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: Acebutolol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01514019

2012_Acebutolol

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

16 participants in 2 patient groups, including a placebo group

Acebutolol

Experimental group

Description:

Acebutolol 200 mg capsule (Acetanol®)

Treatment:

Drug: Acebutolol

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo