Clinical trial NCT01657071: Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects
Official title: A Randomized, Open-label, Single Dose, 2-treatment, 2-period, 2-way Crossover Study to Assess the Pharmacokinetic Characteristics of YH14659, a Fixed Dose Combination Compared With Coadministration of Separate Constituents Under Fasted Conditions in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Coronary Syndrome
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2012-08-03
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 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:

* Healthy male volunteers of aged between 20 years to 55 years
* Weight: over 50kg, within ±20% of ideal body weight
* 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
* Subject who has signed on the written consent

Exclusion Criteria:

* Have a known allergy or hypersensitivity to anti-platelet agents
* Person with hypotension (SBP ≤ 100mmHg or DBP ≤ 50mmHg) or hypertension (SBP ≥ 150mmHg or DBP ≥ 95mmHg), person whose pulse rate is below 45 or over 100 a minute
* 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 180,000 or above 350,000
* Patients with hemorrhage or predisposition to hemorrhage
* Have disease or history of stomach or intestinal surgery or resection that would potentially alter absorption of orally administered drugs
* Have participated in other clinical studies within 3 months prior to the first administration
* Have used any prescription medications including anti-coagulants, anti-platelet agents, thrombolytic drugs and Prostaglandin E1 agents within 2 weeks prior to the first administration or any over-the-counter, non-prescription preparations within 1 week prior to the first administration
* Patients with aspirin induced asthma(AIA) or history of AIA
* Subject who is judged to be ineligible by principal investigator or sub-investigator

Primary outcomes:
measure: Cmax and AUCt of clopidogrel
timeFrame: 24hrs
measure: Cmax and AUCt of Acetylsalicylic acid
timeFrame: 24hrs
Secondary outcomes:
measure: Tmax, T1/2, λz and AUC∞ of Clopidogrel and Acetylsalicylic acid - AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid
timeFrame: 24hrs
measure: AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid
timeFrame: 24hrs
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yuhan Corporation
Study officials:
affiliation: Chung-Nam National University Hospital
name: Jang-Hee Hong, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: