Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects

Phase 1

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: YH14659; Drug: clopidogrel & aspirin

• Registration Number: NCT01657071
• Lead Sponsor: Yuhan Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-21
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-07
• Study First Submitted QC: 2012-08-02
• Last Update Submitted: 2012-08-02
• Study First Posted: 2012-08-03
• Last Update Posted: 2012-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	YH14659	-
Group B	clopidogrel & aspirin	-

Primary Outcome Measures

Name	Time	Method
Cmax and AUCt of clopidogrel	24hrs
Cmax and AUCt of Acetylsalicylic acid	24hrs

Secondary Outcome Measures

Name	Time	Method
Tmax, T1/2, λz and AUC∞ of Clopidogrel and Acetylsalicylic acid - AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid	24hrs
AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid	24hrs

Trial Locations

Locations (1)

Yuhan Corporation; 🇰🇷 Seoul, Korea, Republic of