Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects

NCT01657071 | Completed Phase 1

• 1 other identifier: YH14659-102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

• Cmax and AUCt of clopidogrel

  24hrs

• Cmax and AUCt of Acetylsalicylic acid

  24hrs

Secondary Outcomes (2)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

Drug: YH14659

Group B

ACTIVE COMPARATOR

Drug: clopidogrel & aspirin

Interventions

YH14659 DRUG

YH14659 capsule by oral

Group A

clopidogrel & aspirin DRUG

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

Group B

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Yuhan Corporation

Seoul, 156-754, South Korea

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Clopidogrel; Aspirin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jang-Hee Hong, M.D., Ph.D.

  Chung-Nam National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2012
• First Posted: August 3, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 3, 2012

Record last verified: 2012-07

Locations

KR (1)