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Sponsored by: |
Grünenthal GmbH |
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Information provided by: | Grünenthal GmbH |
ClinicalTrials.gov Identifier: | NCT00469053 |
The purpose of this study is to determine whether two different analgesic transdermal patch formulations lead to same plasma levels of active ingredient after multiple dose application.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Buprenorphine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Multiple Dose Bioequivalence Trial Comparing a Down-Scaled New Analgesic Transdermal Patch Formulation to an Analgesic Reference Patch (Protocol ID: 855509) |
Estimated Enrollment: | 36 |
Study Start Date: | May 2007 |
Study Completion Date: | November 2007 |
Main: To demonstrate the bioequivalence of the new transdermal patch versus the current transdermal patch (Reference) after multiple patch application.
Pharmacokinetic target parameters are AUCss, and Css,max. Further: To assess the safety, tolerability, skin tolerability and adhesiveness of the patch applications. To evaluate the following further Pharmacokinetic parameters: Css,min, Css,ave, PTF, Swing, tss,max, and t1/2,z
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
systolic blood pressure < 90 and > 160 mmHg, diastolic blood pressure < 40 and > 100 mmHg
Caffeine containing beverages or food (tea, coffee, cola, chocolate, etc.) Quinine containing beverages or food (bitter lemon, tonic water) Grapefruit juice (sweet, sour) Poppy seeds containing beverages or food;
Trial specific exclusion criteria:
Study ID Numbers: | 855509 |
Study First Received: | April 18, 2007 |
Last Updated: | November 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00469053 History of Changes |
Health Authority: | Germany: Landesärztekammer Baden-Württemberg |
Transdermal patch multidose Centrally acting analgesic Plasma level Healthy volunteers |
Buprenorphine Narcotic Antagonists Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Healthy Analgesics, Opioid |
Buprenorphine Sensory System Agents Therapeutic Uses Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants |
Narcotics Peripheral Nervous System Agents Analgesics Central Nervous System Agents Analgesics, Opioid Pharmacologic Actions |