Status:
COMPLETED
Study to Compare Pharmacokinetic Profiles of TRK-100STP in Japanese, Chinese, and South Korean Non-elderly Healthy Adult Males
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Toray Industries, Inc
Conditions:
Healthy Adult Male
Pharmacokinetics of TRK-100-STP
Eligibility:
MALE
20-44 years
Phase:
PHASE1
Brief Summary
A study to evaluate the pharmacokinetics and safety of TRK-100STP in Japanese, Chinese, and South Korean non-elderly healthy adult males.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01423435
Start Date
August 1 2011
End Date
September 1 2011
Last Update
October 4 2011
Active Locations (1)
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1
Kyushu, Japan