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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00502879 |
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Date of registration:
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16/07/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Evaluating Etanercept 25mg or 50mg Administered Subcutaneously to Healthy Chinese Male Subjects
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Scientific title:
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A Randomized, Open-Label, Single-Dose Administration, Parallel-Group Study of the Pharmacokinetics of Etanercept, 25mg or 50 mg, Administered Subcutaneously to Healthy Chinese Male Subjects |
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Date of first enrolment:
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July 2007 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00502879 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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China
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For China: medinfo@wyeth.com |
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Key inclusion & exclusion criteria
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1. Men, aged 18 to 45 years, of Chinese descent and living in China.
2. Body mass index in the range of 18.0 to 30.0 kg/meter squared and body weight equal
to or greater than 50 kg.
3. Healthy as determined by the investigator on the basis of medical history, physical
examination, clinical laboratory test results, vital signs, chest x-ray, and 12-lead
electrocardiogram (ECG).
4. Have a high probability for compliance with and completion of the study.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: Enbrel (etanercept)
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Primary Outcome(s)
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To assess the pharmacokinetics of etanercept in healthy Chinese male subjects.
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Secondary ID(s)
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0881A1-1109
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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