An Investigator- And Subjects- Blind Phase 1 Study To Investigate Pharmacokinetics, Safety And Tolerability Of Sitaxentan In Japanese Healthy Subjects Following Single And Multiple Doses And Western Healthy Subjects Following Single Dose
An Investigator- And Subjects- Blind Phase 1 Study To Investigate Pharmacokinetics, Safety And Tolerability Of Sitaxentan In Japanese Healthy Subjects Following Single And Multiple Doses And Western Healthy Subjects Following Single Dose
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.
Inclusion Criteria:
Healthy male and/or female subjects between the age of 18 and 55 years, inclusive.
Body Mass Index of 17.5 to 33.5 kg/m2, and a total body weight >45 kg. Mean body weight and the body weight range of Western subjects are similar to those of Japanese subjects with a 10% plus and minus error.
Exclusion Criteria:
Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.