- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01445964
Effect of SLCO2B1 Genotype and Apple Juice on Pharmacokinetics of Atenolol After Oral Administration in Healthy Male Korean
January 20, 2012 updated by: In-Jin Jang, MD, PhD, Seoul National University Hospital
An Open-label, Single-dose, Three-treatment, Three-period Study to Investigate the Effect of SLCO2B1 Genotype and Apple Juice on Pharmacokinetics of Atenolol After Oral Administration in Healthy Male Korean
An open-label, single-dose, three-treatment, three-period study to investigate the effect of SLCO2B1 genotype and apple juice on pharmacokinetics of atenolol after oral administration in healthy male Korean.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 (atenolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
SLCO2B1 wild type allele
|
Atenolol oral administration
Atenolol oral administration with apple juice 1200 mL
Atenolol oral administration with apple juice 600 mL
|
Experimental: 2
SLCO2B1 variant allele
|
Atenolol oral administration
Atenolol oral administration with apple juice 1200 mL
Atenolol oral administration with apple juice 600 mL
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC of atenolol according to the SLCO2B1 genotypes
Time Frame: 0-48 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.
|
0-48 hr after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure of the subjects who administered atenolol according to the SLCO2B1 genotypes
Time Frame: 0-48 hr after drug admnistration
|
Blood pressure measurement will be presented as descriptive statistics for the difference from baseline where appropriate.
|
0-48 hr after drug admnistration
|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 0-48 hr after drug admnistration
|
Number of participants with adverse event as a measure of safety and tolerability *Measure of safety and tolerability: physical examinations, ECG, Laboratory tests (including hematology, chemistry, urinalysis) - Descriptive statistics will be calculated for quantitative safety data as well as for the difference from baseline where appropriate. |
0-48 hr after drug admnistration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: In-Jin Jang, MD, PhD, Seoul National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
April 29, 2011
First Submitted That Met QC Criteria
September 30, 2011
First Posted (Estimate)
October 4, 2011
Study Record Updates
Last Update Posted (Estimate)
January 23, 2012
Last Update Submitted That Met QC Criteria
January 20, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Atenolol
Other Study ID Numbers
- SNUCPT11_ATE
- Pan Asian-Atenolol-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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