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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663038
• Other study ID #: 119HPS10F
• Status: Completed
• Phase: Phase 1
• First received: December 20, 2010
• Last updated: August 10, 2012
• Start date: December 2010
• Est. completion date: September 2011

Study information

• Verified date: August 2012
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Clopidogrel
Clopidogrel and Aspirin separate combination, single dose
• Fixed dose combination of clopidogrel/Aspirin
Fixed dose combination of clopidogrel/aspirin
• Aspirin

Locations

Country	Name	City	State
Korea, Republic of	Inje University Pusan Paik Hospital	Pusan

Sponsors (2)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical	Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No