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Study Evaluating Etanercept 25mg or 50mg Administered Subcutaneously to Healthy Chinese Male Subjects

Last updated on May 11, 2018

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Study Location
Beijing, , 100730 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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NCT00502879
Pfizer
Completed
Study Evaluating Etanercept 25mg or 50mg Administered Subcutaneously to Healthy Chinese Male Subjects

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Study Evaluating Etanercept 25mg or 50mg Administered Subcutaneously to Healthy Chinese Male Subjects
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
The primary purpose of this study is to assess the pharmacokinetics of etanercept in healthy Chinese male subjects. Safety and tolerability data will also be obtained.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
Drug: Enbrel (etanercept)
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
August 2007
Not Provided
  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.
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00502879
0881A1-1109
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For China: [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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