Single Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations (Protocol ID 297307)
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|ClinicalTrials.gov Identifier: NCT00469404|
Recruitment Status : Terminated (The trial end was achieved according to the definition in the trial protocol)
First Posted : May 4, 2007
Last Update Posted : November 16, 2007
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Buprenorphine||Phase 1|
Main: To demonstrate the bioequivalence between the two transdermal analgesic formulations after single patch application. Pharmacokinetic target parameters are AUC, AUC0-t, and Cmax.
Further: To assess the safety, tolerability, skin tolerability and adhesiveness of the patch applications.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single Dose Bioequivalence Trial Comparing a Down-Scaled New Analgesic Transdermal Patch Formulation to an Analgesic Reference Patch.|
|Study Start Date :||May 2007|
|Actual Study Completion Date :||November 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469404
|Principal Investigator:||Wolfgang Timmer, Dr.||CRS Clinical Research Services Mannheim|