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NCT Number: NCT01340248

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 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.

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Key information

Conditions

Chronic Stable Angina Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kyungpook national university

Daegu, Seoul, 700-721, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Between 20 aged and 50 aged in healthy adults
  • Weight more than 55kg, IBW 20% within the range
  • Agreement with written informed consent

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Dilatrend 64mg capsule

Drug
  • Dilatrend 64mg capsule during fasting + Dilatrend 64mg capsule after high fat diet
  • Dilatrend 64mg capsule after high fat diet + Dilatrend 64mg capsule during fasting

Primary outcomes

  1. 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

Secondary outcomes

  1. evaluation of safety

    Time frame: from screenig to post-study visit

    • adverse event monitoring
    • physical examination, vital sign, ECOG, laboratory test

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 22, 2011
Registry last updated
Dec 22, 2011

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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