Comparative Pharmacokinetics of YH14659 (YH14659)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: YH14659; Drug: clopidogrel & aspirin

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-754
    • Yuhan Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Drug: YH14659; YH14659 capsule by oral
Active Comparator: Group B	Drug: clopidogrel & aspirin; clopidogrel tablet(75mg) + aspirin capsules(100mg) by oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Cmax of salicylic acid, the major active metabolite of aspirin	14 days
AUCt of salicylic acid, the major active metabolite of aspirin	14 days

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: Jae-Gook Shin, MD, PhD., Inje University

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: August 16, 2011
• First Submitted That Met QC Criteria: August 21, 2011
• First Posted (Estimate): August 23, 2011

Study Record Updates

• Last Update Posted (Estimate): January 9, 2012
• Last Update Submitted That Met QC Criteria: January 5, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Aspirin; Clopidogrel; YH14659; Yuhan
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Clopidogrel
• Other Study ID Numbers: YH14659-101