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

NCT ID: NCT01423435

Last Updated: 2011-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-09-30

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.

Detailed Description

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Conditions

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Healthy Adult Male Pharmacokinetics of TRK-100-STP

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Japanese

Group Type EXPERIMENTAL

TRK-100STP

Intervention Type DRUG

oral

Chinese

Group Type EXPERIMENTAL

TRK-100STP

Intervention Type DRUG

oral

South Korean

Group Type EXPERIMENTAL

TRK-100STP

Intervention Type DRUG

oral

Interventions

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TRK-100STP

oral

Intervention Type DRUG

Other Intervention Names

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beraprost Careload LA YM533

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

44 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Toray Industries, Inc

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Use Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

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Kyushu, , Japan

Site Status

Countries

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Japan

Other Identifiers

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533-CL-006

Identifier Type: -

Identifier Source: org_study_id