Back to results

Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

YH14659

clopidogrel & aspirin

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

20 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Yuhan Corporation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Outcomes

Primary Outcome Measures

Cmax and AUCt of clopidogrel

Cmax and AUCt of Acetylsalicylic acid

Secondary Outcome Measures

Tmax, T1/2, λz and AUC∞ of Clopidogrel and Acetylsalicylic acid - AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid

AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid

Full Information

NCT ID

NCT01657071

First Posted

March 21, 2012

Last Updated

August 2, 2012

Sponsor

Yuhan Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01657071

Brief Title

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

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yuhan Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Title

Group B

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

YH14659

Intervention Description

YH14659 capsule by oral

Intervention Type

Drug

Intervention Name(s)

clopidogrel & aspirin

Intervention Description

clopidogrel tablet(75mg) + aspirin capsules(100mg) by oral

Primary Outcome Measure Information:

Title

Cmax and AUCt of clopidogrel

Time Frame

24hrs

Title

Cmax and AUCt of Acetylsalicylic acid

Time Frame

24hrs

Secondary Outcome Measure Information:

Title

Tmax, T1/2, λz and AUC∞ of Clopidogrel and Acetylsalicylic acid - AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid

Time Frame

24hrs

Title

AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid

Time Frame

24hrs

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jang-Hee Hong, M.D., Ph.D.

Organizational Affiliation

Chung-Nam National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yuhan Corporation

City

Seoul

ZIP/Postal Code

156-754

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects

We'll reach out to this number within 24 hrs