Essential HypertensionPhase 1NCT01819870
Study to Compare the Pharmacokinetic Characteristics and Safety of Dilatrend SR Capsule 32mg and Dilatrend Tablet 25mg
A Phase 1 study testing Dilatrend SR capsule 32mg and Dilatrend IR tablet 25mg in people with Essential Hypertension and Chronic Stable Angina, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the pharmacokinetic characteristics and safety of dilatrend SR capsule 32mg and Dilatrend tablet 25mg in healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Essential Hypertension, Chronic Stable Angina, Congestive Heart Failure
- What is being tested?
- Dilatrend SR capsule 32mg and Dilatrend IR tablet 25mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Aug 2013
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 20 aged and 35aged in healthy male
- Body Weight more than 50kg, and within 20% of ideal body weight(IBW).
- IBW(kg) = {height(cm)-100}*0.9
- Have not any congenital or chronic disease and medical symptoms.
- Suitable results of inspections(laboratory test, ECG, etc) within 21 days before IP administration.
- Agreement with written informed consent
Who cannot join
- Subject has hypersensitivity reaction or clinically significant history about carvedilol or investigator drug.
- Clinically significant cardiovascular system, respiratory system, liver, kidney, endocrine system, gastrointestinal system, central nervous system, blood tumor, mental disease, skin disease, otorhinolaryngologic diseases and so on.
- Hypotension(SBP < 105mmHg or DBP < 65mmHg), Hypertension(SBP > 150mmHg or DBP > 100mmHg)
- Heart rate < 50times/minute
- Active liver disease or AST, ALT > 1.5*upper limit of normal range
- Creatinine clearance < 80mL/min
Show all 17Show fewer
- Subject has a disease affecting drug's ADME or gastrointestinal surgery.
- Subject with symptoms of injured or acute disease within 28days before the first IP administration.
- Subject has a history of drug abuse or a positive reaction for drug abuse at the screening test for urine.
- Taking ETC medicine including oriental medicine within 14days before the first IP administration or Taking OTC medicine within 7days
- Subject takes an abnormal meal which affect the ADME of drug.
- Previously participate in other trial within 90days.
- Previously make whole blood donation within 60days or component blood donation within 30days before the first IP administration.
- Continued to be taking caffeine(caffeine > 5cup/day), drinking(alcohol > 21unit/week, 1unit = 10g = 12.5mL of pure alcohol) or during clinical trials can not be drunk or severe heavy smoker(cigarette > 10cigarettes/day).
- Subject with positive reaction about serum test(HBsAg, HCV Ab, HIV Ag/Ab, VDRL)
- Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption.
- 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
Kyungpook National University Hospital Clinical Trial Center
Daegu, Eok-dong 2(i)-ga Jung-gu, 700-721
About this study
Official title: A Randomized, Open-label, Multiple-dose, Crossover Phase I Study to Compare the Pharmacokinetic Characteristics and Safety of Dilatrend SR Capsule 32 mg and Dilatrend Tablet 25 mg in Healthy Male Subjects
The purpose of this study is to compare the pharmacokinetic characteristics and safety of dilatrend SR capsule 32mg and Dilatrend tablet 25mg in healthy male subjects.
Read the detailed description
Healthy male subjects are administrated multiple-dose over the period I and II (Crossover) of dilatrend SR capsule 32mg and dilatrend tablet 25mg.
- Being tested
- Dilatrend SR capsule 32mg, Dilatrend IR tablet 25mg
- Keywords
- Carvedilol, Dilatrend SR capsule, Dilatrend Tablet, Pharmacokinetics, Healthy male subjects
- Medical subject headings
- Essential Hypertension, Angina, Stable, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dilatrend SR capsule 32mgDrug
- 1 capsule, oral, once daily, 7days
- over the period I\&II(crossover)
Dilatrend IR tablet 25mgDrug
- 1 tablet, oral, once daily, 7days
- over the period I\&II(crossover)
| Study group | Role | What they receive |
|---|---|---|
| Dilatrend SR capsule 32mg | Experimental | Not described Receives: Drug: Dilatrend SR capsule 32mg |
| Dilatrend IR tablet 25mg | Active comparator | Not described Receives: Drug: Dilatrend IR tablet 25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg AUCtau
AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 48 hours sample) determined using the linear trapezoidal rule
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
Secondary outcomes (6)
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg AUCinf
AUCinf: Area Under the Concentration time curve with the last concentration extrapolated based on the elimination rate constant Kel
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Css,max
Css,max : Maximum drug concentration in plasma determined directly from individual concentration-time data
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Css,min
Css,min : Minimum drug concentration in plasma determined directly from individual concentration-time data
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Tss,max
Tss,max : Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg t½
t½ : Observed terminal elimination half-life
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
Number of participants with adverse events
- Evaluated safety parameters included: physical examination, vital sign, laboratory test, ECG
- adverse event monitoring
Measured: From 1day to 37 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young-Ran Yoon, Principal investigator, Kyungpook National University Hospital Clinical Trial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819870
- Sponsor's protocol ID
- 125HPS12006
- Status last verified
- Jan 2013
- First submitted
- 20 Mar 2013
- Last updated
- 1 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple-dose, Crossover Phase I Study to Compare the Pharmacokinetic Characteristics and Safety of Dilatrend SR Capsule 32 mg and Dilatrend Tablet 25 mg in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01819870
- Acronym / sponsor ID
- 125HPS12006
- Keywords
- Carvedilol, Dilatrend SR capsule, Dilatrend Tablet, Pharmacokinetics, Healthy male subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- May 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 28 Mar 2013 (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.
The purpose of this study is to compare the pharmacokinetic characteristics and safety of dilatrend SR capsule 32mg and Dilatrend tablet 25mg in healthy male subjects.
Detailed description
Healthy male subjects are administrated multiple-dose over the period I and II (Crossover) of dilatrend SR capsule 32mg and dilatrend tablet 25mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dilatrend SR capsule 32mg | Experimental | Drug: Dilatrend SR capsule 32mg |
| Dilatrend IR tablet 25mg | Active comparator | Drug: Dilatrend IR tablet 25mg |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Between 20 aged and 35aged in healthy male
- Body Weight more than 50kg, and within 20% of ideal body weight(IBW).
- Have not any congenital or chronic disease and medical symptoms.
- Suitable results of inspections(laboratory test, ECG, etc) within 21 days before IP administration.
- Agreement with written informed consent
Key exclusion criteria (17 listed)
- Subject has hypersensitivity reaction or clinically significant history about carvedilol or investigator drug.
- Clinically significant cardiovascular system, respiratory system, liver, kidney, endocrine system, gastrointestinal system, central nervous system, blood tumor, mental disease, skin disease, otorhinolaryngologic diseases and so on.
- Hypotension(SBP < 105mmHg or DBP < 65mmHg), Hypertension(SBP > 150mmHg or DBP > 100mmHg)
- Heart rate < 50times/minute
- Active liver disease or AST, ALT > 1.5*upper limit of normal range
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 capsule 32mg* 1 capsule, oral, once daily, 7days * over the period I\&II(crossover) | Drug | Dilatrend SR capsule 32mg |
| Dilatrend IR tablet 25mg* 1 tablet, oral, once daily, 7days * over the period I\&II(crossover) | Drug | Dilatrend IR tablet 25mg |
Primary outcome
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg AUCtau
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 48 hours sample) determined using the linear trapezoidal rule
6 secondary outcomes
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg AUCinf
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Css,max
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Css,min
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Tss,max
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg t½
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
Number of participants with adverse events
Time frame: From 1day to 37 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2013.
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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.
Young-Ran Yoon principal investigator
Kyungpook National University Hospital Clinical Trial 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 32mg and Dilatrend IR tablet 25mg in people with Essential Hypertension and 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 6 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 1 Apr 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Young-Ran Yoon (053-420-4950, yry@knu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg AUCtau (time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)). 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 1 Apr 2013.