Chronic Stable AnginaPhase 1NCT01369472
Evaluating Dose-proportionality of Dilatrend Suspended-Release Capsule
A Phase 1 study testing Dilatrend SR capsule in people with Chronic Stable Angina, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This study is designed to evaluate dose-proportionality of Dilatrend SR 8mg, 16mg, 32mg, 64mg, 128mg in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 54 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Stable Angina
- What is being tested?
- Dilatrend SR capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Oct 2011
- 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 54 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range 20 to 54 years, Body mass index of ≥19 and ≤26 healthy male volunteers
- Able to participate in all procedure
- SBP 90-140 mmHg, DBP 60-90 mmHg, Pulse rate 55-95 times/min
- Have given written informed consent
Who cannot join
- Have history of significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, musculoskeletal neurologic disease
- Have history of gastrointestinal disease(Crohn's disease, gastrointestinal ulcer) or surgery(except for Appendectomy, Hernia)
- Have allergy or hypersensitivity to carvedilol or any component of the formulation(aspirin, antibiotics)
- Have history of drug abuse. A positive test for any drug(amphetamine, barbiturates, cocaine, opiates, benzodiazepines, THC, methadone, ect.) included in the urine drug screen.
- Have herbal drug within 30days prior to the first IP administration, have ETC within 14days prior to the first IP administration, have OTC 7days prior to the first IP administration.
- Have diet which may influence on the absorption, distribution, metabolism or excretion of drug(s), (Drinking over 1L of grapefruit juice within 7days prior to the first IP administration)
Show all 11Show fewer
- Have received an investigational drug within 60 days prior to the first IP administration
- Have donated whole blood within 60 days prior or donation plasma within 30 days prior to the first IP administration
- Have any metabolic enzyme including or inhibiting drugs like barbiturates within 30 days prior to the first IP administration.
- A heavy caffeine/alcohol consumer or a heavy smoker(caffeine > 5 units/days. alcohol >21 units/week (1 unit=pure alcohol 10mL), Cigarette > 10 Cigarettes/day) or alcohol abuse.
- Positive for Hepatitis B, Hepatitis C, HIV or syphilis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single Dose, Dose-rising 10-sequence, 3-period Balanced Incomplete Blocked Clinical Trial to Evaluate Dose-proportionality of Dilatrend SR in Healthy Male Volunteers
This study is designed to evaluate dose-proportionality of Dilatrend SR 8mg, 16mg, 32mg, 64mg, 128mg in healthy male volunteers.
- Conditions
- Chronic Stable Angina
- Being tested
- Dilatrend SR capsule
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dilatrend SR capsuleDrug
single oral administration in period 1 or 2, 3 for each sequential group.
| Study group | Role | What they receive |
|---|---|---|
| Dilatrend SR capsule 8mg | Experimental | Not described Receives: Drug: Dilatrend SR capsule |
| Dilatrend SR capsule 16mg | Experimental | Not described Receives: Drug: Dilatrend SR capsule |
| Dilatrend SR capsule 32mg | Experimental | Not described Receives: Drug: Dilatrend SR capsule |
| Dilatrend SR capsule 64mg | Experimental | Not described Receives: Drug: Dilatrend SR capsule |
| Dilatrend SR capsule 128mg | Experimental | Not described Receives: Drug: Dilatrend SR capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-proportionality
AUClast
Measured: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Dose-proportionality
AUC0-∞
Measured: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Dose-proportionality
Cmax
Measured: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Dose-proportionality
Tmax
Measured: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Dose-proportionality
t½β
Measured: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Secondary outcomes (1)
Safety
Adverse Event/Serious Adverse Event monitoring Physical Examination, Vital Sign, 12-lead ECG, Lab Tests
Measured: 0(predose), 4, 8, 12, 24, 36, 48h and follow-up visit(22d±1d)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stable AnginaStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center
- Investigators
- KS Bae, Ph.D, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369472
- Sponsor's protocol ID
- 125HPS11E
- Status last verified
- Feb 2012
- First submitted
- 21 Apr 2011
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Dose-rising 10-sequence, 3-period Balanced Incomplete Blocked Clinical Trial to Evaluate Dose-proportionality of Dilatrend SR in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01369472
- Acronym / sponsor ID
- 125HPS11E
- Conditions
- Chronic Stable Angina
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 9 Jun 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.
This study is designed to evaluate dose-proportionality of Dilatrend SR 8mg, 16mg, 32mg, 64mg, 128mg in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dilatrend SR capsule 8mg | Experimental | Drug: Dilatrend SR capsule |
| Dilatrend SR capsule 16mg | Experimental | Drug: Dilatrend SR capsule |
| Dilatrend SR capsule 32mg | Experimental | Drug: Dilatrend SR capsule |
| Dilatrend SR capsule 64mg | Experimental | Drug: Dilatrend SR capsule |
| Dilatrend SR capsule 128mg | Experimental | Drug: Dilatrend SR capsule |
Who may qualify
- Ages
- 20 to 54 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age range 20 to 54 years, Body mass index of ≥19 and ≤26 healthy male volunteers
- Able to participate in all procedure
- SBP 90-140 mmHg, DBP 60-90 mmHg, Pulse rate 55-95 times/min
- Have given written informed consent
Key exclusion criteria (11 listed)
- Have history of significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, musculoskeletal neurologic disease
- Have history of gastrointestinal disease(Crohn's disease, gastrointestinal ulcer) or surgery(except for Appendectomy, Hernia)
- Have allergy or hypersensitivity to carvedilol or any component of the formulation(aspirin, antibiotics)
- Have history of drug abuse. A positive test for any drug(amphetamine, barbiturates, cocaine, opiates, benzodiazepines, THC, methadone, ect.) included in the urine drug screen.
- Have herbal drug within 30days prior to the first IP administration, have ETC within 14days prior to the first IP administration, have OTC 7days prior to the first IP administration.
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 |
|---|---|---|
| Dilatrend SR capsulesingle oral administration in period 1 or 2, 3 for each sequential group. | Drug | Dilatrend SR capsule 128mg, Dilatrend SR capsule 16mg, Dilatrend SR capsule 32mg, Dilatrend SR capsule 64mg, Dilatrend SR capsule 8mg |
Primary outcome
Dose-proportionality
Time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
AUClast
Dose-proportionality
Time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
AUC0-∞
Dose-proportionality
Time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Cmax
Dose-proportionality
Time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Tmax
Dose-proportionality
Time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
t½β
1 secondary outcome
Safety
Time frame: 0(predose), 4, 8, 12, 24, 36, 48h and follow-up visit(22d±1d)
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 15 Feb 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.
KS Bae, Ph.D principal investigator
Asan Medical Center
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 Dilatrend SR capsule in people with Chronic Stable Angina, run by Chong Kun Dang Pharmaceutical 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 4 inclusion and 11 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 15 Feb 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 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?
Dose-proportionality (time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h). The study lists 5 primary outcomes in all. 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 15 Feb 2012.