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

Purpose

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Aspirin Clopidogrel bisulfate

U.S. FDA Resources

Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
Assess Cmax, AUC, Tmax and t1/2(half-life) of clodiogrel/acetylsalicylic acid.

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
Assess Cmax, AUC, Tmax, t1/2(Half-life) of salicylic acid.

Enrollment:	60
Study Start Date:	August 2011
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	20 Years to 55 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:	NCT01496261 History of Changes
Other Study ID Numbers:	132HPS11I
Study First Received:	December 18, 2011
Last Updated:	December 20, 2011
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Chong Kun Dang Pharmaceutical:

Clopidogrel
Aspirin
Combination
Pharmacokinetics
Phase 1

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics

ClinicalTrials.gov processed this record on June 18, 2013