HealthyPhase 4NCT01445964
Effect of SLCO2B1 Genotype and Apple Juice on Pharmacokinetics of Atenolol After Oral Administration in Healthy Male Korean
A Phase 4 study testing Atenolol, Atenolol with apple juice 1200 mL and Atenolol with apple juice 600 mL in people with Healthy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Atenolol, Atenolol with apple juice 1200 mL and Atenolol with apple juice 600 mL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- A subject with history of allergies including study drug (atenolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Atenolol, Atenolol with apple juice 1200 mL, Atenolol with apple juice 600 mL
- Keywords
- SLCO2B1 genotype, effect of apple juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtenololDrug
Atenolol oral administration
Atenolol with apple juice 1200 mLDrug
Atenolol oral administration with apple juice 1200 mL
Atenolol with apple juice 600 mLDrug
Atenolol oral administration with apple juice 600 mL
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | SLCO2B1 wild type allele Receives: Drug: Atenolol; Drug: Atenolol with apple juice 1200 mL; Drug: Atenolol with apple juice 600 mL |
| 2 | Experimental | SLCO2B1 variant allele Receives: Drug: Atenolol; Drug: Atenolol with apple juice 1200 mL; Drug: Atenolol with apple juice 600 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of atenolol according to the SLCO2B1 genotypes
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.
Measured: 0-48 hr after drug administration
Secondary outcomes (2)
Blood pressure of the subjects who administered atenolol according to the SLCO2B1 genotypes
Blood pressure measurement will be presented as descriptive statistics for the difference from baseline where appropriate.
Measured: 0-48 hr after drug admnistration
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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.
Measured: 0-48 hr after drug admnistration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Jin Jang, MD, PhD, Seoul National University Hospital
- Investigators
- In-Jin Jang, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445964
- Sponsor's protocol ID
- SNUCPT11_ATE
- Other IDs
- Pan Asian-Atenolol-1
- Status last verified
- Jan 2012
- First submitted
- 29 Apr 2011
- Last updated
- 23 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01445964
- Acronym / sponsor ID
- SNUCPT11_ATE
- Conditions
- Healthy
- Keywords
- SLCO2B1 genotype, effect of apple juice
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Atenolol, Drug: Atenolol with apple juice 1200 mL, Drug: Atenolol with apple juice 600 mLSLCO2B1 wild type allele |
| 2 | Experimental | Drug: Atenolol, Drug: Atenolol with apple juice 1200 mL, Drug: Atenolol with apple juice 600 mLSLCO2B1 variant allele |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- A subject with history of allergies including study drug (atenolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtenololAtenolol oral administration | Drug | 1, 2 |
| Atenolol with apple juice 1200 mLAtenolol oral administration with apple juice 1200 mL | Drug | 1, 2 |
| Atenolol with apple juice 600 mLAtenolol oral administration with apple juice 600 mL | Drug | 1, 2 |
Primary outcome
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.
2 secondary outcomes
Blood pressure of the subjects who administered atenolol according to the SLCO2B1 genotypes
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Jin Jang, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atenolol, Atenolol with apple juice 1200 mL and Atenolol with apple juice 600 mL in people with Healthy, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of atenolol according to the SLCO2B1 genotypes (time frame: 0-48 hr after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2012; AzTrials last refreshed its copy on 8 Nov 2026.