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Completed

NCT Number: NCT01422109

Comparative Pharmacokinetics of YH14659

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

  • 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

Treatment and study plan

YH14659

Drug

YH14659 capsule by oral

Clopidogrel & Aspirin

Drug

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

Primary outcomes

  1. Maximum plasma concentration(Cmax) of clopidogrel

    Time frame: 14 days

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

    Time frame: 14 days

  3. Maximum plasma concentration(Cmax) of acetylsalicylic acid

    Time frame: 14 days

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

    Time frame: 14 days

Secondary outcomes

  1. Cmax of salicylic acid, the major active metabolite of aspirin

    Time frame: 14 days

  2. AUCt of salicylic acid, the major active metabolite of aspirin

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Acronym: YH14659

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 23, 2011
Registry last updated
Jan 9, 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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