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Evaluating Dose-proportionality of Dilatrend Suspended-Release Capsule

This study has been completed.
Sponsor:
Collaborator:
Asan Medical Center
Information provided by:
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01369472
First received: April 21, 2011
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

This study is designed to evaluate dose-proportionality of Dilatrend SR 8mg, 16mg, 32mg, 64mg, 128mg in healthy male volunteers.


Condition Intervention Phase
Chronic Stable Angina
Drug: Dilatrend SR capsule
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • Dose-proportionality [ Time Frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h ] [ Designated as safety issue: Yes ]
    AUClast

  • Dose-proportionality [ Time Frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h ] [ Designated as safety issue: Yes ]
    AUC0-∞

  • Dose-proportionality [ Time Frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h ] [ Designated as safety issue: Yes ]
    Cmax

  • Dose-proportionality [ Time Frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h ] [ Designated as safety issue: Yes ]
    Tmax

  • Dose-proportionality [ Time Frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h ] [ Designated as safety issue: Yes ]
    t½β


Secondary Outcome Measures:
  • Safety [ Time Frame: 0(predose), 4, 8, 12, 24, 36, 48h and follow-up visit(22d±1d) ] [ Designated as safety issue: Yes ]
    Adverse Event/Serious Adverse Event monitoring Physical Examination, Vital Sign, 12-lead ECG, Lab Tests


Enrollment: 30
Study Start Date: June 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 54 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369472

Locations
Korea, Republic of
Asan Medcial Center
Songpa-gu, Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Asan Medical Center
Investigators
Principal Investigator: KS Bae, Ph.D Asan Medical Center
  More Information

No publications provided

Responsible Party: Jin Kim / Director, Clincal Research Department
ClinicalTrials.gov Identifier: NCT01369472     History of Changes
Other Study ID Numbers: 125HPS11E
Study First Received: April 21, 2011
Last Updated: February 13, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Angina, Stable
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases
Carvedilol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic beta-Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014