The purpose of this study is to investigate safety, tolerability and pharmacokinetics of sitaxentan following single and multiple oral administrations of sitaxentan sodium in Japanese healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
22
100 mg and 200 mg, tablet, single and multiple oral doses for 7 days
100 mg and 200 mg, tablet, single oral dose
Pfizer Investigational Site
Glendale, California, United States
Adverse events (spontaneous and solicited)
Time frame: Day 0 to Day 9 of Period 3 for cohort 1, Day 0 to Day 3 of Period 2 for cohort 2
ECGs, Vital signs, Safety laboratory test
Time frame: Screening visit to Day 9 of Period 3 for cohort 1 and Day 3 of Period 2 for cohort 2
Pharmacokinetics (single dose): Cmax, Tmax, AUC, t1/2, CL/F and V/F
Time frame: Day 1 of Periods 1 and 2
Pharmacokinetics (multiple dose): Cmax, Tmax, Ctrough, AUC, t1/2, CL/F, V/F, Rac and Rss
Time frame: Days 1 and 7 of Periods 1 and 3
No secondary outcome
Time frame: No secondary outcome
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