The purpose of this study is to see how safe an investigational new drug (T89) is and how well healthy Japanese subjects tolerate it when given two single doses and a multiple dose.
This is a single centre, double-blind, randomized, placebo controlled, single- and multiple- dose-escalation study. After informed consent is obtained, subjects were evaluated with a medical history questionnaire, physical examination, blood and urine collections for clinical laboratory safety tests, urine drug screen, serum pregnancy test for each women, vital signs and ECG. The subjects who fulfill the inclusion criteria but no exclusion criteria were provisionally enrolled. For participation in this trial, subjects were instructed to avoid any prescription, over-the-counter (OTC), and alternative / complementary medications or significant changes in diet without advance permission from principal investigator. The subjects were instructed to discontinue alcohol, caffeine and bromine containing beverage/food. 20 subjects were enrolled and divided into three Groups: Group A, Group B and Group C.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
20
150mg single dose on day 1
150mg single dose
300mg single dose
California Clinical Trial Medical Group
Glendale, California, United States
Incidence of Adverse Drug Events and Serious Adverse Events
the Incidence of Adverse Drug Events and serious adverse events
Time frame: 30 days (after first dosing)
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300mg single dose
225mg bid
225mg bid