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

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ClinicalTrials.gov Identifier: NCT01496261
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : December 21, 2011
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Clopidogrel and Aspirin Drug: Fixed dose combination of clopidogrel/aspirin Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2011
Primary Completion Date : September 2011
Study Completion Date : September 2011

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Clopidogrel and Aspirin Drug: Clopidogrel and Aspirin
Clopidogrel and Aspirin seperate combination, single dose
Other Names:
  • Clopidogrel: Plavix
  • Aspirin: Astrix
Experimental: Coprigerl Drug: Fixed dose combination of clopidogrel/aspirin
Fixed dose combination of clopidogrel/aspirin
Other Name: Coprigrel


Outcome Measures

Primary Outcome Measures :
  1. Assess the pharmacokinetic characteristics 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 ]
    Assess Cmax, AUC, Tmax and t1/2(half-life) of clodiogrel/acetylsalicylic acid.


Secondary Outcome Measures :
  1. Assess the pharmacokinetic characteristics 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 ]
    Assess Cmax, AUC, Tmax, t1/2(Half-life) of salicylic acid.


Eligibility Criteria

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496261


Locations
Korea, Republic of
Inje University Pusan Paik Hospital
Jin-gu, Pusan, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Inje University
Investigators
Principal Investigator: JL Ghim, Dr. Inje University
More Information

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01496261     History of Changes
Other Study ID Numbers: 132HPS11I
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: December 21, 2011
Last Verified: December 2011

Keywords provided by Chong Kun Dang Pharmaceutical:
Clopidogrel
Aspirin
Combination
Pharmacokinetics
Phase 1

Additional relevant MeSH terms:
Aspirin
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents