Evaluating Dose-proportionality of Dilatrend Suspended-Release Capsule

February 13, 2012 updated by: Chong Kun Dang Pharmaceutical

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoul
      • Songpa-gu, Seoul, Korea, Republic of, 138-736
        • Asan Medcial Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Age range 20 to 54 years, Body mass index of ≥19 and ≤26 healthy male volunteers
  2. Able to participate in all procedure
  3. SBP 90-140 mmHg, DBP 60-90 mmHg, Pulse rate 55-95 times/min
  4. Have given written informed consent

Exclusion Criteria:

  1. Have history of significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, musculoskeletal neurologic disease
  2. Have history of gastrointestinal disease(Crohn's disease, gastrointestinal ulcer) or surgery(except for Appendectomy, Hernia)
  3. Have allergy or hypersensitivity to carvedilol or any component of the formulation(aspirin, antibiotics)
  4. 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.
  5. 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.
  6. 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)
  7. Have received an investigational drug within 60 days prior to the first IP administration
  8. Have donated whole blood within 60 days prior or donation plasma within 30 days prior to the first IP administration
  9. Have any metabolic enzyme including or inhibiting drugs like barbiturates within 30 days prior to the first IP administration.
  10. 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.
  11. Positive for Hepatitis B, Hepatitis C, HIV or syphilis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dilatrend SR capsule 8mg
Drug: Dilatrend SR capsule
single oral administration in period 1 or 2, 3 for each sequential group.
Experimental: Dilatrend SR capsule 16mg
Drug: Dilatrend SR capsule
single oral administration in period 1 or 2, 3 for each sequential group.
Experimental: Dilatrend SR capsule 32mg
Drug: Dilatrend SR capsule
single oral administration in period 1 or 2, 3 for each sequential group.
Experimental: Dilatrend SR capsule 64mg
Drug: Dilatrend SR capsule
single oral administration in period 1 or 2, 3 for each sequential group.
Experimental: Dilatrend SR capsule 128mg
Drug: Dilatrend SR capsule
single oral administration in period 1 or 2, 3 for each sequential group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose-proportionality
Time Frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
AUClast
0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Dose-proportionality
Time Frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
AUC0-∞
0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Dose-proportionality
Time Frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Cmax
0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Dose-proportionality
Time Frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Tmax
0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Dose-proportionality
Time Frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
t½β
0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 0(predose), 4, 8, 12, 24, 36, 48h and follow-up visit(22d±1d)
Adverse Event/Serious Adverse Event monitoring Physical Examination, Vital Sign, 12-lead ECG, Lab Tests
0(predose), 4, 8, 12, 24, 36, 48h and follow-up visit(22d±1d)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chong Kun Dang Pharmaceutical

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Asan Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: KS Bae, Ph.D, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 125HPS11E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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