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

This study has been completed.
Sponsor:
Collaborator:
Toray Industries, Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01423435
First received: August 24, 2011
Last updated: October 2, 2011
Last verified: October 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy Adult Male
Pharmacokinetics of TRK-100-STP
 Drug: TRK-100STP
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Pharmacokinetic Study of TRK-100STP -A Single Oral Administration Study in Japanese, Chinese, and South Korean Non-elderly Healthy Adult Males -

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety assessed by the incidence of adverse events, vital signs, 12-lead electrocardiograms (ECGs) and lab tests [ Time Frame: Up to 6 days ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: August 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Japanese Drug: TRK-100STP
oral
Other Names:
  • beraprost
  • Careload LA
  • YM533
Experimental: Chinese Drug: TRK-100STP
oral
Other Names:
  • beraprost
  • Careload LA
  • YM533
Experimental: South Korean Drug: TRK-100STP
oral
Other Names:
  • beraprost
  • Careload LA
  • YM533

  Eligibility

Ages Eligible for Study:   20 Years to 44 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423435

Locations
Japan
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Toray Industries, Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01423435     History of Changes
Other Study ID Numbers: 533-CL-006
Study First Received: August 24, 2011
Last Updated: October 2, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
TRK-100STP
PK
beraprost sodium

Additional relevant MeSH terms:
Beraprost
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013