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Comparative Pharmacokinetics Study of Clopidogrel and Aspirin Fixed-dose Combination Versus Separate Combination

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Clopidogrel
Fixed dose combination of clopidogrel/Aspirin
Aspirin
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Clopidogrel, Aspirin, Combination, Pharmacokinetics, Phase 1

Eligibility Criteria

20 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • A healthy male volunteer aged 20 to 55, and within 20% of ideal body weight.
  • Have not any congenital or chronic diseases and medical symptom.
  • Appropriate subject for the study judging from examinations(interview, vital signs, 12-lead ECG, physical examination, blood, urinalysis result on screening.
  • Able to participate in the entire trial.
  • Signed the informed consent form prior to study participation.

Exclusion Criteria:

  • Take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first IP administration.
  • show evidence of acute disease within 28 days prior to the first IP administration.
  • Have the medical history of bleeding symptom or bleeding disease
  • Have the disease history(ex. Inflammatory intestinal disease, stomach or duodenum ulcer, liver and bowels disease, appendectomy except of gastrointestinal surgery history) that may influence on the absorption, distribution, metabolism and excretion of the drug.
  • Have relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that does not need medication.
  • Have hypersensitivity reaction histories for Clopidogrel or aspirin.
  • Have abnormal laboratory result. AST or ALT > 1.25 times of upper limit/ Total bilirubin > 1.5 times of upper limit/ PT, aPTT, BT over upper limit/ Platelet count <150X10^9/L or >350X10^9/L
  • A drug abuse or a heavy caffeine consumer (more than 5cups per a day) or a heavy smoker (more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first IP administration.
  • Have a diet(Especially, grapefruit juice-within 7days prior to the first IP administration) that may influence on the absorption, distribution, metabolism and excretion of the drug(s).
  • Have donated whole blood within 60 days prior to the first IP administration.
  • Participated in the other clinical trials within 90days prior to the first IP administration.
  • Take medicine which affect to this trial within 10 days prior to the first IP administration.
  • Appropriate subject for the trial judging from principal investigator.

Sites / Locations

  • Inje University Pusan Paik Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Clopidogrel and Aspirin

Copidogrel

Arm Description

Outcomes

Primary Outcome Measures

Cmax of clopidogrel/acetylsalicylic acid
AUC of clopidogrel/acetylsalicylic acid

Secondary Outcome Measures

Assess Cmax of salicylic acid.
Assess AUC of salicylic acid.

Full Information

First Posted
December 20, 2010
Last Updated
August 10, 2012
Sponsor
Chong Kun Dang Pharmaceutical
Collaborators
Inje University
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1. Study Identification

Unique Protocol Identification Number
NCT01663038
Brief Title
Comparative Pharmacokinetics Study of Clopidogrel and Aspirin Fixed-dose Combination Versus Separate Combination
Official Title
Comparative Pharmacokinetics of Clopidogrel 75mg and Aspirin 100mg After Single Oral Administration as a Fixed Dose Combination Versus Separate Combination in Healthy Male Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical
Collaborators
Inje University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare pharmacokinetics between fixed-dose combination and separate combination of clopidogrel 75mg/aspirin 100mg.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Clopidogrel, Aspirin, Combination, Pharmacokinetics, Phase 1

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Clopidogrel and Aspirin
Arm Type
Active Comparator
Arm Title
Copidogrel
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Clopidogrel: Plavix
Intervention Description
Clopidogrel and Aspirin separate combination, single dose
Intervention Type
Drug
Intervention Name(s)
Fixed dose combination of clopidogrel/Aspirin
Other Intervention Name(s)
Coprigrel
Intervention Description
Fixed dose combination of clopidogrel/aspirin
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Aspirin: Astrix
Primary Outcome Measure Information:
Title
Cmax of clopidogrel/acetylsalicylic acid
Time Frame
Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
Title
AUC of clopidogrel/acetylsalicylic acid
Time Frame
Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
Secondary Outcome Measure Information:
Title
Assess Cmax of salicylic acid.
Time Frame
Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
Title
Assess AUC of salicylic acid.
Time Frame
Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A healthy male volunteer aged 20 to 55, and within 20% of ideal body weight. Have not any congenital or chronic diseases and medical symptom. Appropriate subject for the study judging from examinations(interview, vital signs, 12-lead ECG, physical examination, blood, urinalysis result on screening. Able to participate in the entire trial. Signed the informed consent form prior to study participation. Exclusion Criteria: Take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first IP administration. show evidence of acute disease within 28 days prior to the first IP administration. Have the medical history of bleeding symptom or bleeding disease Have the disease history(ex. Inflammatory intestinal disease, stomach or duodenum ulcer, liver and bowels disease, appendectomy except of gastrointestinal surgery history) that may influence on the absorption, distribution, metabolism and excretion of the drug. Have relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that does not need medication. Have hypersensitivity reaction histories for Clopidogrel or aspirin. Have abnormal laboratory result. AST or ALT > 1.25 times of upper limit/ Total bilirubin > 1.5 times of upper limit/ PT, aPTT, BT over upper limit/ Platelet count <150X10^9/L or >350X10^9/L A drug abuse or a heavy caffeine consumer (more than 5cups per a day) or a heavy smoker (more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first IP administration. Have a diet(Especially, grapefruit juice-within 7days prior to the first IP administration) that may influence on the absorption, distribution, metabolism and excretion of the drug(s). Have donated whole blood within 60 days prior to the first IP administration. Participated in the other clinical trials within 90days prior to the first IP administration. Take medicine which affect to this trial within 10 days prior to the first IP administration. Appropriate subject for the trial judging from principal investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JH Shon, Ph.D
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University Pusan Paik Hospital
City
Pusan
Country
Korea, Republic of

12. IPD Sharing Statement

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Comparative Pharmacokinetics Study of Clopidogrel and Aspirin Fixed-dose Combination Versus Separate Combination

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