Comparative Pharmacokinetics of YH14659

Acute Coronary Syndrome Clinical Trial

— YH14659  

Official title:

Comparative Pharmacokinetics After Single Oral Administration of YH14659, a Fixed Dose Combination Versus Coadministration of Separate Constituents in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422109
• Other study ID #: YH14659-101
• Status: Completed
• Phase: Phase 1
• First received: August 16, 2011
• Last updated: January 5, 2012
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: January 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: 44
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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	Maximum plasma concentration(Cmax) of clopidogrel		14 days	No
Primary	Area under the time-concentration curve to last concentration(AUCt) of clopidogrel		14 days	No
Primary	Maximum plasma concentration(Cmax) of acetylsalicylic acid		14 days	No
Primary	Area under the time-concentration curve to last concentration(AUCt) of acetylsalicylic acid		14 days	No
Secondary	Cmax of salicylic acid, the major active metabolite of aspirin		14 days	No
Secondary	AUCt of salicylic acid, the major active metabolite of aspirin		14 days	No