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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00502879 |
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.
Condition | Intervention | Phase |
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Healthy |
Drug: Enbrel (etanercept) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment |
Official Title: | 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 |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Study ID Numbers: | 0881A1-1109 |
Study First Received: | July 16, 2007 |
Last Updated: | December 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00502879 History of Changes |
Health Authority: | China: State Food and Drug Administration |
Anti-Inflammatory Agents Immunologic Factors Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents |
Analgesics Healthy Antirheumatic Agents TNFR-Fc fusion protein Immunosuppressive Agents |
Anti-Inflammatory Agents Immunologic Factors Physiological Effects of Drugs Gastrointestinal Agents TNFR-Fc fusion protein Immunosuppressive Agents Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |