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

Astellas

Status and phase

Completed

Phase 1

Conditions

Pharmacokinetics of TRK-100-STP

Healthy Adult Male

Treatments

Drug: TRK-100STP

Study type

Interventional

Funder types

Industry

Identifiers

NCT01423435

533-CL-006

Details and patient eligibility

About

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

Enrollment

36 patients

Sex

Male

Ages

20 to 44 years old

Volunteers

Accepts Healthy Volunteers

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