Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects

Acute Coronary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657071
• Other study ID #: YH14659-102
• Status: Completed
• Phase: Phase 1
• First received: March 21, 2012
• Last updated: August 2, 2012
• Start date: March 2012
• Est. completion date: April 2012

Study information

• Verified date: July 2012
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Drug:
• YH14659
YH14659 capsule by oral
• clopidogrel & aspirin
clopidogrel tablet(75mg) + aspirin capsules(100mg) by oral

Locations

Country	Name	City	State
Korea, Republic of	Yuhan Corporation	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax and AUCt of clopidogrel		24hrs	No
Primary	Cmax and AUCt of Acetylsalicylic acid		24hrs	No
Secondary	Tmax, T1/2, ?z and AUC8 of Clopidogrel and Acetylsalicylic acid - AUCt, Cmax, Tmax, T1/2, ?z and AUC8 of salicylic acid		24hrs	No
Secondary	AUCt, Cmax, Tmax, T1/2, ?z and AUC8 of salicylic acid		24hrs	No