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Completed

NCT Number: NCT01657071

Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects

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.

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Key information

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Yuhan Corporation

Seoul, 156-754, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YH14659

Drug

YH14659 capsule by oral

Clopidogrel & Aspirin

Drug

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

Primary outcomes

  1. Cmax and AUCt of clopidogrel

    Time frame: 24hrs

  2. Cmax and AUCt of Acetylsalicylic acid

    Time frame: 24hrs

Secondary outcomes

  1. 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

  2. AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid

    Time frame: 24hrs

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 3, 2012
Registry last updated
Aug 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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