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

NCT01663038 | Completed Phase 1

• 1 other identifier: 119HPS10F
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease

Keywords

Clopidogrel; Aspirin; Combination; Pharmacokinetics; Phase 1

Outcome Measures

Primary Outcomes (2)

• Cmax of clopidogrel/acetylsalicylic acid

  Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h

• AUC of clopidogrel/acetylsalicylic acid

  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 (2)

• Assess Cmax of salicylic acid.

  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 AUC of salicylic acid.

  Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h

Study Arms (2)

Clopidogrel and Aspirin

ACTIVE COMPARATOR

Drug: Clopidogrel; Drug: Aspirin

Copidogrel

EXPERIMENTAL

Drug: Fixed dose combination of clopidogrel/Aspirin

Interventions

Clopidogrel DRUG

Clopidogrel and Aspirin separate combination, single dose

Also known as: Clopidogrel: Plavix

Clopidogrel and Aspirin

Fixed dose combination of clopidogrel/Aspirin DRUG

Fixed dose combination of clopidogrel/aspirin

Also known as: Coprigrel

Copidogrel

Aspirin DRUG

Also known as: Aspirin: Astrix

Clopidogrel and Aspirin

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead
• Inje University: collaborator

Study Sites (1)

Inje University Pusan Paik Hospital

Pusan, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Clopidogrel; Aspirin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• JH Shon, Ph.D

  Inje University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: August 13, 2012
• Study Start: December 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: September 1, 2011
• Last Updated: August 13, 2012

Record last verified: 2012-08

Locations

KR (1)