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Completed

NCT Number: NCT01369472

Evaluating Dose-proportionality of Dilatrend Suspended-Release Capsule

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

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Key information

Age range

20 year–54 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medcial Center

Songpa-gu, Seoul, 138-736, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

Dilatrend SR capsule

Drug

single oral administration in period 1 or 2, 3 for each sequential group.

Primary outcomes

  1. Dose-proportionality

    Time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h

    AUClast

  2. Dose-proportionality

    Time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h

    AUC0-∞

  3. Dose-proportionality

    Time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h

    Cmax

  4. Dose-proportionality

    Time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h

    Tmax

  5. Dose-proportionality

    Time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h

    t½β

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Collaborators

  • Asan Medical Center

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 9, 2011
Registry last updated
Feb 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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