Clinical trial NCT01663038: Comparative Pharmacokinetics Study of Clopidogrel and Aspirin Fixed-dose Combination Versus Separate Combination
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronary Artery Disease
Keywords: Clopidogrel
Aspirin
Combination
Pharmacokinetics
Phase 1
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Inje University
First posted: 2012-08-13
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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 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.

Primary outcomes:
measure: Cmax of clopidogrel/acetylsalicylic acid
timeFrame: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
measure: AUC of clopidogrel/acetylsalicylic acid
timeFrame: 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:
measure: Assess Cmax of salicylic acid.
timeFrame: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
measure: Assess AUC of salicylic acid.
timeFrame: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
Other outcomes:
Locations:
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
Study officials:
affiliation: Inje University
name: JH Shon, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: