Study to Compare Pharmacokinetic Profiles of TRK-100STP in Japanese, Chinese, and South Korean Non-elderly Healthy Adult Males

Study Overview
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Brief Summary
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A study to evaluate the pharmacokinetics and safety of TRK-100STP in Japanese, Chinese, and South Korean non-elderly healthy adult males.

Official Title
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A Pharmacokinetic Study of TRK-100STP -A Single Oral Administration Study in Japanese, Chinese, and South Korean Non-elderly Healthy Adult Males -

Conditions
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Healthy Adult Male, Pharmacokinetics of TRK-100-STP

Intervention / Treatment
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* Drug: TRK-100STP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body weight: =<50.0 to 80.0> kg BMI: =<17.6 to 26.4> Subjects whose condition an investigator/subinvestigator has confirmed to be healthy by the date of drug administration, based on the screening test results Exclusion Criteria: Subjects who received an investigational drug within 120 days prior to the screening test in other clinical trials or post-marketing studies Subjects who had 400 mL whole blood drawing within 90 days prior to the screening test, who had 200 mL whole blood drawing within 30 days prior to the screening test, or had component blood drawing within 14 days prior to the screening test Subjects who has received or will receive any drug treatment including over the counter (OTC) drugs within 7 days prior to the day of confinement Subjects whose vital signs are out of the standard level in one of the following parameters at the time of the screening test or the day of confinement: blood pressure, pulse rate, body temperature, and 12-lead ECG Subjects who have had upper Gastro-Intestinal (GI) symptoms within 7 days prior to the day of confinement (1 day prior to the drug administration): nausea, vomiting, or stomachache Subjects who have complications or history of liver diseases: viral hepatitis or chronic bronchitis Subjects who have complications or history of Cardio Vascular (CV) diseases: chronic heart failure, angina, or arrythmia that needs treatment Subjects who have complications or history of respiratory diseases: severe bronchial asthma or chronic bronchitis. History of pediatric asthma is not included Subjects who have complications or history of respiratory diseases: severe peptic ulceration or gastro-esophageal reflux disease. History of appendicitis is not included Subjects who have complications or history of renal diseases: acute renal failure, glomerulonephritis, or interstitial nephritis. History of calculus is not included Subjects who have complications or history of cerebrovascular diseases including cerebral infarction Subjects who have complications or history of malignant tumors Subjects in whom the daily amount of alcohol or smoking is excessive Subjects who have received beraprost

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Japanese<br> | Drug: TRK-100STP<br>* oral<br>* Other names: YM533;|
| Experimental: Chinese<br> | Drug: TRK-100STP<br>* oral<br>* Other names: YM533;|
| Experimental: South Korean<br> | Drug: TRK-100STP<br>* oral<br>* Other names: YM533;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of pharmacokinetic parameters of TRK-100STP such as maximum observed concentration (Cmax), area under the serum concentration-time curve (AUC) and terminal half-life (t1/2) |  | Up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by the incidence of adverse events, vital signs, 12-lead electrocardiograms (ECGs) and lab tests |  | Up to 6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TRK-100STP, PK, beraprost sodium