Kyushu, Japan
NCT Number: NCT01423435
Study to Compare Pharmacokinetic Profiles of TRK-100STP in Japanese, Chinese, and South Korean Non-elderly Healthy Adult Males
A study to evaluate the pharmacokinetics and safety of TRK-100STP in Japanese, Chinese, and South Korean non-elderly healthy adult males.
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Notify MeKey information
Age range
20 year–44 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
TRK-100STP
Drugoral
Other names: beraprost, Careload LA, YM533
Primary outcomes
-
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)
Time frame: Up to 48 hours
Secondary outcomes
-
Safety assessed by the incidence of adverse events, vital signs, 12-lead electrocardiograms (ECGs) and lab tests
Time frame: Up to 6 days
Sponsors and collaborators
Lead sponsor
Astellas Pharma Inc
Industry
Collaborators
- Toray Industries, Inc
Registry information
Official study title
A Pharmacokinetic Study of TRK-100STP -A Single Oral Administration Study in Japanese, Chinese, and South Korean Non-elderly Healthy Adult Males -
Important dates
- Study start
- 2011
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Aug 26, 2011
- Registry last updated
- Oct 4, 2011
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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