Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects
This study has been completed.
Sponsor:
Yuhan Corporation
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01657071
First received: March 21, 2012
Last updated: August 2, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Coronary Syndrome |
Drug: YH14659 Drug: clopidogrel & aspirin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open-label, Single Dose, 2-treatment, 2-period, 2-way Crossover Study to Assess the Pharmacokinetic Characteristics of YH14659, a Fixed Dose Combination Compared With Coadministration of Separate Constituents Under Fasted Conditions in Healthy Male Subjects |
Resource links provided by NLM:
Further study details as provided by Yuhan Corporation:
Primary Outcome Measures:
- Cmax and AUCt of clopidogrel [ Time Frame: 24hrs ] [ Designated as safety issue: No ]
- Cmax and AUCt of Acetylsalicylic acid [ Time Frame: 24hrs ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Tmax, T1/2, λz and AUC∞ of Clopidogrel and Acetylsalicylic acid - AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid [ Time Frame: 24hrs ] [ Designated as safety issue: No ]
- AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid [ Time Frame: 24hrs ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | March 2012 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group A |
Drug: YH14659
YH14659 capsule by oral
|
| Active Comparator: Group B |
Drug: clopidogrel & aspirin
clopidogrel tablet(75mg) + aspirin capsules(100mg) by oral
|
Eligibility| Ages Eligible for Study: | 20 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657071
Locations
| Korea, Republic of | |
| Yuhan Corporation | |
| Seoul, Korea, Republic of, 156-754 | |
Sponsors and Collaborators
Yuhan Corporation
Investigators
| Principal Investigator: | Jang-Hee Hong, M.D., Ph.D. | Chung-Nam National University Hospital |
More Information
No publications provided
| Responsible Party: | Yuhan Corporation |
| ClinicalTrials.gov Identifier: | NCT01657071 History of Changes |
| Other Study ID Numbers: | YH14659-102 |
| Study First Received: | March 21, 2012 |
| Last Updated: | August 2, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris Vascular Diseases Chest Pain Pain Signs and Symptoms Aspirin Clopidogrel Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |
ClinicalTrials.gov processed this record on June 18, 2013