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Study Evaluating Enbrel Drug Levels in Healthy Male Chinese Subjects

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NCT00705042

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Guangzhou, Guangdong, 510006 China
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
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.
Show details

Healthy male Chinese subjects, ages 18 to 45. BMI in the range of 18 to 30 kg/m2 and weight
greater than or equal to 50 kg.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Active tuberculosis (TB) or history of TB. Serious infection (associated with
hospitalization and/or antibiotics) within 1 month before study drug administration.

History of protein drug hypersensitivity.

NCT00705042
Pfizer
Completed
Study Evaluating Enbrel Drug Levels in Healthy Male Chinese Subjects

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Study Evaluating Enbrel Drug Levels in Healthy Male Chinese Subjects
A Randomized, Open-Label, Single-Dose Administration, Parallel-Group, Multisite Study of the Pharmacokinetics of Etanercept, 25 or 50 mg, Administered Subcutaneously to Healthy Chinese Male Subjects
The purpose of this study is to evaluate the Pharmacokinetics (PK) and safety and tolerability of etanercept, 25 and 50 mg, administered as a single dose to healthy male Chinese subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy Subjects
Drug: Etanercept
  • Experimental: A
    25 mg
    Intervention: Drug: Etanercept
  • Experimental: B
    50 mg
    Intervention: Drug: Etanercept
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2008
September 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Healthy male Chinese subjects, ages 18 to 45. BMI in the range of 18 to 30 kg/m2 and weight greater than or equal to 50 kg.

Exclusion Criteria:

Active tuberculosis (TB) or history of TB. Serious infection (associated with hospitalization and/or antibiotics) within 1 month before study drug administration.

History of protein drug hypersensitivity.
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00705042
0881A1-1110
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 2009

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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