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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

Primary Purpose

Chronic Stable Angina

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dilatrend 64mg capsule
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stable Angina focused on measuring food effect, pharmacokinetics, healthy male volunteers

Eligibility Criteria

20 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Kyungpook national university

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dilatrend 64mg capsule

Arm Description

* Randomized, open-label, single dose, two-period, two-way, crossover study group : Dilatrend 64mg capsule during fasting + Dilatrend 64mg capsule after high fat diet group : Dilatrend 64mg capsule after high fat diet + Dilatrend 64mg capsule during fasting

Outcomes

Primary Outcome Measures

evaluation of pharmacokinetics
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 Outcome Measures

evaluation of safety
adverse event monitoring physical examination, vital sign, ECOG, laboratory test

Full Information

First Posted
April 20, 2011
Last Updated
December 20, 2011
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01340248
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stable Angina
Keywords
food effect, pharmacokinetics, healthy male volunteers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dilatrend 64mg capsule
Arm Type
Experimental
Arm Description
* Randomized, open-label, single dose, two-period, two-way, crossover study group : Dilatrend 64mg capsule during fasting + Dilatrend 64mg capsule after high fat diet group : Dilatrend 64mg capsule after high fat diet + Dilatrend 64mg capsule during fasting
Intervention Type
Drug
Intervention Name(s)
Dilatrend 64mg capsule
Intervention Description
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 Outcome Measure Information:
Title
evaluation of pharmacokinetics
Description
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
Time Frame
pre-dose(0h), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48h
Secondary Outcome Measure Information:
Title
evaluation of safety
Description
adverse event monitoring physical examination, vital sign, ECOG, laboratory test
Time Frame
from screenig to post-study visit

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Kyungpook national university
City
Daegu
State/Province
Seoul
ZIP/Postal Code
700-721
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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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