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CompletedNCT01496261Updated Dec 21, 2011

Comparative Pharmacokinetics Study of Clopidogrel and Aspirin Fixed-dose Combination Versus Separate Combination-2nd Trial

A Phase 1 interventional study of Clopidogrel and Aspirin and Fixed dose combination of clopidogrel/aspirin in Coronary Artery Disease, sponsored by Chong Kun Dang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-12-21.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Clopidogrel
  • Aspirin
  • Combination
  • Pharmacokinetics
  • Phase 1
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 60 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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 doesn't 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Clopidogrel and Aspirin

    Drug: Clopidogrel and Aspirin

  • Experimental
    Coprigerl

    Drug: Fixed dose combination of clopidogrel/aspirin

Interventions

  • DrugClopidogrel and Aspirin

    Clopidogrel and Aspirin seperate combination, single dose

    Also known as: Clopidogrel: Plavix, Aspirin: Astrix

  • DrugFixed dose combination of clopidogrel/aspirin

    Fixed dose combination of clopidogrel/aspirin

    Also known as: Coprigrel

06

What researchers measure

Primary outcomes

  1. Assess the pharmacokinetic characteristics of clodiogrel/acetylsalicylic acid.

    Assess Cmax, AUC, Tmax and t1/2(half-life) of clodiogrel/acetylsalicylic acid.

    Time frame: FDAAA) 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 outcomes

  1. Assess the pharmacokinetic characteristics of salicylic acid.

    Assess Cmax, AUC, Tmax, t1/2(Half-life) 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

07

Study locations

1 site
  • Inje University Pusan Paik Hospital
    Jin-gu, Pusan, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01496261
Lead sponsor
Chong Kun Dang Pharmaceutical
Collaborators
Inje University
Responsible party
Sponsor
First posted
Dec 21, 2011
Start date
Aug 2011
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Dec 21, 2011

Study contacts

JL Ghim, Dr.
principal investigator · Inje University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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