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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Japanese Cohort | Experimental | Single and multiple oral doses of sitaxentan sodium or placebo in 12 healthy subjects. |
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| Western Cohort | Experimental | Single oral dose of sitaxentan sodium in 10 healthy subjects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitaxentan sodium/Placebo | Drug | 100 mg and 200 mg, tablet, single and multiple oral doses for 7 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (spontaneous and solicited) | 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 | 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 | Day 1 of Periods 1 and 2 | |
| Pharmacokinetics (multiple dose): Cmax, Tmax, Ctrough, AUC, t1/2, CL/F, V/F, Rac and Rss | Days 1 and 7 of Periods 1 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| No secondary outcome | No secondary outcome |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Glendale | California | 91206 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Sitaxentan sodium/Placebo | Drug | 100 mg and 200 mg, tablet, single oral dose |
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