Comparative Pharmacokinetics of YH14659

NCT01422109 | Completed Phase 1 DMC

• 1 other identifier: YH14659-101
• Study Type: interventional
• Target: 44
• 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

Keywords

YH14659; Aspirin; Clopidogrel; Yuhan

Outcome Measures

Primary Outcomes (4)

• Maximum plasma concentration(Cmax) of clopidogrel

  14 days

• Area under the time-concentration curve to last concentration(AUCt) of clopidogrel

  14 days

• Maximum plasma concentration(Cmax) of acetylsalicylic acid

  14 days

• Area under the time-concentration curve to last concentration(AUCt) of acetylsalicylic acid

  14 days

Secondary Outcomes (2)

• Cmax of salicylic acid, the major active metabolite of aspirin

  14 days

• AUCt of salicylic acid, the major active metabolite of aspirin

  14 days

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:

• The patient or legally authorized representative must sign a written informed consent, prior to the any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug
• Healthy male volunteers of aged between 20 years to 55 years
• Have standard weight of ≤ ±20% based on Broca index\* (Broca index: ideal weight(kg) = (height(cm)-100) x 0.9)
• 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

You may not qualify if:

• Received any drug that induce or/and inhibit drug metabolizing enzyme such as barbital within the last 28 days prior to the first administration
• Shown symptoms doubtful as an acute disease within the last 28 days prior to the first administration
• Have signs of bleeding symptoms or/and history of disease such as: gum bleeding, hard to control hemorrhage, easily suffer from bruise, and etc.
• Have disease that can affect absorption, distribution, metabolism and excretion of the drug such as: inflammatory bowel disease, gastric ulcer, duodenal ulcer, hepatic disorders, and gastrointestinal tract surgery except appendectomy
• Have a known allergy(except mild allergic rhinitis which does not require treatment) or hypersensitivity to drugs
• 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 150,000 or above 350,000
• Have been drug abuse, excessive caffeine (\> 5 cups/day), heavy smoking (\>10 cigarettes/day), continuous alcohol intake (\> 30g/day) or have drunk within the last 7 days prior to the first administration
• Have been on a diet that can affect absorption, distribution, metabolism and excretion of the drug (especially grapefruit juice 7 days prior to the first administration)
• Donated blood within 60 days prior to the first administration
• Participated in any other clinical trials within 60 days prior to the first administration
• Have used any drug which is thought to affect this study by principal investigator 10 days prior to the first administration

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

• Jae-Gook Shin, MD, PhD.

  Inje University

  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: August 16, 2011
• First Posted: August 23, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 9, 2012

Record last verified: 2012-01

Locations

KR (1)