Clinical trial NCT01422109: Comparative Pharmacokinetics of YH14659
Official title: Comparative Pharmacokinetics After Single Oral Administration of YH14659, a Fixed Dose Combination Versus Coadministration of Separate Constituents in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Coronary Syndrome
Keywords: YH14659
Aspirin
Clopidogrel
Yuhan
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2011-08-23
Enrollment: 44
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 objective of this study is to compare pharmacokinetics after single oral administration of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* The patient or legally authorized representative must sign a written informed consent, prior to the any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug
* Healthy male volunteers of aged between 20 years to 55 years
* Have standard weight of ≤ ±20% based on Broca index\* (Broca index: ideal weight(kg) = (height(cm)-100) x 0.9)
* Have no history of neither congenital nor chronic disease
* Have no history of abnormal symptoms or opinions as a result of physical examination (medical checkup)
* Eligible subjects with acceptable medical history, physical examination laboratory tests, ECG during screening period

Exclusion Criteria:

* Received any drug that induce or/and inhibit drug metabolizing enzyme such as barbital within the last 28 days prior to the first administration
* Shown symptoms doubtful as an acute disease within the last 28 days prior to the first administration
* Have signs of bleeding symptoms or/and history of disease such as: gum bleeding, hard to control hemorrhage, easily suffer from bruise, and etc.
* Have disease that can affect absorption, distribution, metabolism and excretion of the drug such as: inflammatory bowel disease, gastric ulcer, duodenal ulcer, hepatic disorders, and gastrointestinal tract surgery except appendectomy
* Have a known allergy(except mild allergic rhinitis which does not require treatment) or hypersensitivity to drugs
* Have the following abnormal findings on diagnosis;

  * have AST or ALT \> 1.25 times of normal upper limit
  * have total bilirubin \> 1.5 times of normal upper limit
  * have higher PT, aPPT, BT than normal range
  * have PLT below 150,000 or above 350,000
* Have been drug abuse, excessive caffeine (\> 5 cups/day), heavy smoking (\>10 cigarettes/day), continuous alcohol intake (\> 30g/day) or have drunk within the last 7 days prior to the first administration
* Have been on a diet that can affect absorption, distribution, metabolism and excretion of the drug (especially grapefruit juice 7 days prior to the first administration)
* Donated blood within 60 days prior to the first administration
* Participated in any other clinical trials within 60 days prior to the first administration
* Have used any drug which is thought to affect this study by principal investigator 10 days prior to the first administration
* Subject who is judged to be ineligible by principal investigator or sub-investigator

Primary outcomes:
measure: Maximum plasma concentration(Cmax) of clopidogrel
timeFrame: 14 days
measure: Area under the time-concentration curve to last concentration(AUCt) of clopidogrel
timeFrame: 14 days
measure: Maximum plasma concentration(Cmax) of acetylsalicylic acid
timeFrame: 14 days
measure: Area under the time-concentration curve to last concentration(AUCt) of acetylsalicylic acid
timeFrame: 14 days
Secondary outcomes:
measure: Cmax of salicylic acid, the major active metabolite of aspirin
timeFrame: 14 days
measure: AUCt of salicylic acid, the major active metabolite of aspirin
timeFrame: 14 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yuhan Corporation
Study officials:
affiliation: Inje University
name: Jae-Gook Shin, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: