HypertensionPhase 1NCT02097511
Sarpogrelate Drug Interaction
A Phase 1 study testing Sarpogrelate pretreatment, Sarpogrelate and Metoprolol in people with Hypertension and Peripheral Artery Disease, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
This is a randomized, open-label, single \& multiple-dose, three-sequence, three-period crossover study to investigate the effect of sarpogrelate hydrochloride on the disposition of metoprolol tartrate in healthy male volunteers Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Peripheral Artery Disease
- What is being tested?
- Sarpogrelate pretreatment, Sarpogrelate and Metoprolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Dec 2014
- Phase
- Phase 1
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 20 - 45 years
- With in 20% of ideal body weight, {Ideal body weight=[height(cm)-100]*0.9}
- Agreement with written informed consent
Who cannot join
- Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
- Inadequate result of laboratory test (especially, AST/ALT > 1.25 x UNL, Total bilirubin > 1.5 x UNL)
- Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test
- Taking OTC(Over the counter)medicine including oriental medicine within 7 days
- Clinically significant allergic disease (Except for mild allergic rhinitis and dermatitis seems to be not need for medication)
- Subject with known for hypersensitivity reaction to Metoprolol or Sarpogrelate
Show all 10Show fewer
- Previous whole blood donation within 60 days or component blood donation within 30 days
- Previous participation of other trial within 90 days
- Continued taking caffeine (caffeine > 5 cup/day), drinking (alcohol > 30 g/day) and severe heavy smoker (cigarette > 1/2 pack per day)
- An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou University School of Medicine
Suwon, Gyeonggi-do, 433-721
About this study
Official title: A Randomized, Open-label, Three-sequence, Three-period Crossover Study to Investigate The Effect of Anplag on the Disposition of Betaloc in Healthy Male Volunteers
This is a randomized, open-label, single \& multiple-dose, three-sequence, three-period crossover study to investigate the effect of sarpogrelate hydrochloride on the disposition of metoprolol tartrate in healthy male volunteers
Read the detailed description
Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trial Center of Ajou University Medical Center on the day before dosing (Day -1).
On Day 1, Subjects will be dosed study drug (metoprolol tartrate 100 mg once a day only, or metoprolol tartrate 100 mg once a day with sarpogrelate hydrochloride 100 mg three times a day, sarpogrelate hydrochloride 100 mg three times a day pretreatment for three days and metoprolol tartrate 100 mg once a day with sarpogrelate hydrochloride 100 mg three times a day).
Pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 12 hours after metoprolol tartrate 100 mg dosing.
After one week of washout period (Day 8), Subjects will be dosed study drug by crossover manner, and pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 12 hours after metoprolol tartrate 100 mg dosing.
After one week of washout period (Day 15), Subjects will be dosed study drug by crossover manner, and pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 12 hours after metoprolol tartrate 100 mg dosing.
- Conditions
- Hypertension, Peripheral Artery Disease
- Being tested
- Sarpogrelate pretreatment, Sarpogrelate, Metoprolol
- Keywords
- Drug-drug interaction, Pharmacokinetics, Pharmacodynamics
- Medical subject headings
- Hypertension, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarpogrelate pretreatmentDrug
Sarpogrelate hydrochloride 100 mg pretreatment three times a day for three days
SarpogrelateDrug
Sarpogrelate hydrochloride 100 mg three times a day
MetoprololDrug
Metoprolol Tartrate 100 mg once a day
| Study group | Role | What they receive |
|---|---|---|
| Sarpogrelate pretreatment and Metoprolol | Experimental | Sarpogrelate hydrochloride 100 mg pretreatment three times a day for three days and Metoprolol Tartrate 100 mg once a day with Sarpogrelate hydrochloride 100 mg three times a day Receives: Drug: Sarpogrelate pretreatment; Drug: Sarpogrelate; Drug: Metoprolol |
| Sarpogrelate and Metoprolol | Active comparator | Metoprolol Tartrate 100 mg once a day with Sarpogrelate hydrochloride 100 mg three times a day Receives: Drug: Sarpogrelate; Drug: Metoprolol |
| Metoprolol only | Active comparator | Metoprolol Tartrate 100 mg once a day Receives: Drug: Metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of Metoprolol and metabolites
Cmax (maximal plasma concentration) and AUC (area under the time-concentration curve) will be calculated from pharmacokinetic samplings
Measured: upto 12 hours after Metoprolol Tartrate 100 mg dosing
Secondary outcomes (1)
Blood pressure and pulse rate changes
Blood pressure and pulse rate measurement with Dash 5000 patient monitoring system (GE Healthcare, USA) at 0 (before Metoprolol Tartrate 100 mg dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12 hours after Metoprolol Tartrate 100 mg dosing
Measured: Upto 12 hours after Metoprolol Tartrate 100 mg dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionJan 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doo-Yeoun Cho, Ajou University School of Medicine
- Investigators
- Doo-Yeoun Cho, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097511
- Sponsor's protocol ID
- DDI-102
- Status last verified
- Feb 2015
- First submitted
- 25 Mar 2014
- Last updated
- 25 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Three-sequence, Three-period Crossover Study to Investigate The Effect of Anplag on the Disposition of Betaloc in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02097511
- Acronym / sponsor ID
- DDI-102
- Conditions
- Hypertension, Peripheral Artery Disease
- Keywords
- Drug-drug interaction, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Mar 2014 (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.
This is a randomized, open-label, single \& multiple-dose, three-sequence, three-period crossover study to investigate the effect of sarpogrelate hydrochloride on the disposition of metoprolol tartrate in healthy male volunteers
Detailed description
Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trial Center of Ajou University Medical Center on the day before dosing (Day -1).
On Day 1, Subjects will be dosed study drug (metoprolol tartrate 100 mg once a day only, or metoprolol tartrate 100 mg once a day with sarpogrelate hydrochloride 100 mg three times a day, sarpogrelate hydrochloride 100 mg three times a day pretreatment for three days and metoprolol tartrate 100 mg once a day with sarpogrelate hydrochloride 100 mg three times a day).
Pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 12 hours after metoprolol tartrate 100 mg dosing.
After one week of washout period (Day 8), Subjects will be dosed study drug by crossover manner, and pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 12 hours after metoprolol tartrate 100 mg dosing.
After one week of washout period (Day 15), Subjects will be dosed study drug by crossover manner, and pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 12 hours after metoprolol tartrate 100 mg dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sarpogrelate pretreatment and Metoprolol | Experimental | Drug: Sarpogrelate pretreatment, Drug: Sarpogrelate, Drug: MetoprololSarpogrelate hydrochloride 100 mg pretreatment three times a day for three days and Metoprolol Tartrate 100 mg once a day with Sarpogrelate hydrochloride 100 mg three times a day |
| Sarpogrelate and Metoprolol | Active comparator | Drug: Sarpogrelate, Drug: MetoprololMetoprolol Tartrate 100 mg once a day with Sarpogrelate hydrochloride 100 mg three times a day |
| Metoprolol only | Active comparator | Drug: MetoprololMetoprolol Tartrate 100 mg once a day |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects aged 20 - 45 years
- With in 20% of ideal body weight, {Ideal body weight=[height(cm)-100]*0.9}
- Agreement with written informed consent
Key exclusion criteria (10 listed)
- Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
- Inadequate result of laboratory test (especially, AST/ALT > 1.25 x UNL, Total bilirubin > 1.5 x UNL)
- Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test
- Taking OTC(Over the counter)medicine including oriental medicine within 7 days
- Clinically significant allergic disease (Except for mild allergic rhinitis and dermatitis seems to be not need for medication)
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 |
|---|---|---|
| Sarpogrelate pretreatmentSarpogrelate hydrochloride 100 mg pretreatment three times a day for three days | Drug | Sarpogrelate pretreatment and Metoprolol |
| SarpogrelateSarpogrelate hydrochloride 100 mg three times a day | Drug | Sarpogrelate and Metoprolol, Sarpogrelate pretreatment and Metoprolol |
| MetoprololMetoprolol Tartrate 100 mg once a day | Drug | Metoprolol only, Sarpogrelate and Metoprolol, Sarpogrelate pretreatment and Metoprolol |
Primary outcome
Plasma concentration of Metoprolol and metabolites
Time frame: upto 12 hours after Metoprolol Tartrate 100 mg dosing
Cmax (maximal plasma concentration) and AUC (area under the time-concentration curve) will be calculated from pharmacokinetic samplings
1 secondary outcome
Blood pressure and pulse rate changes
Time frame: Upto 12 hours after Metoprolol Tartrate 100 mg dosing
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 25 Feb 2015.
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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.
Doo-Yeoun Cho, MD principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sarpogrelate pretreatment, Sarpogrelate and Metoprolol in people with Hypertension and Peripheral Artery Disease, run by Ajou University School of Medicine 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 3 inclusion and 10 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 25 Feb 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Plasma concentration of Metoprolol and metabolites (time frame: upto 12 hours after Metoprolol Tartrate 100 mg dosing). 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 25 Feb 2015.