Chronic Stable AnginaPhase 1NCT01340248
A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Dilatrend SR 64mg Capsule After Oral Administration in Healthy Male Volunteers
A Phase 1 study testing Dilatrend 64mg capsule in people with Chronic Stable Angina, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect on the pharmacokinetics of Dilatrend SR 64mg capsule after oral administration in healthy male volunteers. 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
- Chronic Stable Angina
- What is being tested?
- Dilatrend 64mg capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Aug 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 20 aged and 50 aged in healthy adults
- Weight more than 55kg, IBW 20% within the range
- Agreement with written informed consent
Who cannot join
- Subject has hypersensitivity reaction or clinically significant history about investigational drug
- Clinically significant cardiovascular system, respiratory system, liver, renal, endocrine system, gastrointestinal system, central nervous system, blood tumor, mental disease, skin disease and so on
- Inadequate result of laboratory test
- AST(SGOT) or ALT(SGPT) > 1.5 x upper limit of normal range
- Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 210 g/day) or during clinical trials can not be drunk or severe heavy smoker (cigarette > 10 cigarettes per day)
- Creatinine clearance < 80ml/min
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- Subject with known for history(such as gastrointestinal disease or operation) with affect the absorption of drug
- Subject takes an abnormal meal which affect the ADME of drug
- Previously participated in other trial within 90 days
- Previously make whole blood donation within 60 days or component blood donation within 30 days
- Subject with positive reaction for reason of laboratory test result
- 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.
About this study
A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect on the pharmacokinetics of Dilatrend SR 64mg capsule after oral administration in healthy male volunteers.
- Conditions
- Chronic Stable Angina
- Being tested
- Dilatrend 64mg capsule
- Keywords
- food effect, pharmacokinetics, healthy male volunteers
- 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 64mg capsuleDrug
- Dilatrend 64mg capsule during fasting + Dilatrend 64mg capsule after high fat diet
- Dilatrend 64mg capsule after high fat diet + Dilatrend 64mg capsule during fasting
| Study group | Role | What they receive |
|---|---|---|
| Dilatrend 64mg capsule | Experimental | * Randomized, open-label, single dose, two-period, two-way, crossover study
1. group : Dilatrend 64mg capsule during fasting + Dilatrend 64mg capsule after high fat diet
2. group : Dilatrend 64mg capsule after high fat diet + Dilatrend 64mg capsule during fasting Receives: Drug: Dilatrend 64mg capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of pharmacokinetics
The effect of food on PK after high fat diet and fasting Blood sampling over a 72 hour period post dose in all dosing sessions
Measured: pre-dose(0h), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48h
Secondary outcomes (1)
evaluation of safety
- adverse event monitoring
- physical examination, vital sign, ECOG, laboratory test
Measured: from screenig to post-study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2011
- Study completionAug 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.
- 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340248
- Sponsor's protocol ID
- 125HPS11F
- Status last verified
- Apr 2011
- First submitted
- 20 Apr 2011
- Last updated
- 22 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Dilatrend SR 64mg Capsule After Oral Administration in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01340248
- Acronym / sponsor ID
- 125HPS11F
- Conditions
- Chronic Stable Angina
- Keywords
- food effect, pharmacokinetics, healthy male volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 22 Apr 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.
A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect on the pharmacokinetics of Dilatrend SR 64mg capsule after oral administration in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dilatrend 64mg capsule | Experimental | Drug: Dilatrend 64mg capsule* Randomized, open-label, single dose, two-period, two-way, crossover study 1. group : Dilatrend 64mg capsule during fasting + Dilatrend 64mg capsule after high fat diet 2. group : Dilatrend 64mg capsule after high fat diet + Dilatrend 64mg capsule during fasting |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between 20 aged and 50 aged in healthy adults
- Weight more than 55kg, IBW 20% within the range
- Agreement with written informed consent
Key exclusion criteria (12 listed)
- Subject has hypersensitivity reaction or clinically significant history about investigational drug
- Clinically significant cardiovascular system, respiratory system, liver, renal, endocrine system, gastrointestinal system, central nervous system, blood tumor, mental disease, skin disease and so on
- Inadequate result of laboratory test
- Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 210 g/day) or during clinical trials can not be drunk or severe heavy smoker (cigarette > 10 cigarettes per day)
- Creatinine clearance < 80ml/min
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 64mg capsule1. Dilatrend 64mg capsule during fasting + Dilatrend 64mg capsule after high fat diet 2. Dilatrend 64mg capsule after high fat diet + Dilatrend 64mg capsule during fasting | Drug | Dilatrend 64mg capsule |
Primary outcome
evaluation of pharmacokinetics
Time frame: pre-dose(0h), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48h
The effect of food on PK after high fat diet and fasting Blood sampling over a 72 hour period post dose in all dosing sessions
1 secondary outcome
evaluation of safety
Time frame: from screenig to post-study visit
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 22 Dec 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 64mg 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 3 inclusion and 12 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 22 Dec 2011. 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?
evaluation of pharmacokinetics (time frame: pre-dose(0h), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48h). 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 22 Dec 2011.