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| Sponsors and Collaborators: |
University of Southern Denmark H. Lundbeck A/S |
|---|---|
| Information provided by: | University of Southern Denmark |
| ClinicalTrials.gov Identifier: | NCT00692263 |
Purpose
Escitalopram will be given to a panel of 16 healthy subject for 9 days. On the ninth day a single dose of tramadol is administered to the subjects and pharmacokinetic(PK) and pharmacodynamic(PD) measurements are done for the next 24 hours.
It is stated that escitalopram is only a weak inhibitor of CYP2D6 and therefore no effect is seen in Pk or PK of tramadol
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: escitalopram and tramadol Drug: placebo Drug: placebo and tramadol |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects |
| Enrollment: | 15 |
| Study Start Date: | February 2008 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Escitalopram - tramadol
|
Drug: escitalopram and tramadol
10 mg escitalopram for 3 days 20 mg escitalopram for 6 days 150 mg tramadol as a single dose on day 9
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B: Experimental
Placebo - tramadol
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Drug: placebo and tramadol
9 days of placebo equivalent to 10 / 20 mg escitalopram, one single dose of 150 mg tramadol on day 9
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C: Experimental
placebo - placebo
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Drug: placebo
placebo identical for 10 mg/ 20 mg escitalopram and 150 mg tramadol
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Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark | |
| Institute of Public Health, Clinical Pharmacology, University of Southern Denmark | |
| Odense, Denmark, DK-5000 | |
| Study Chair: | Kim Brosen, MD, D.Sc | Institute of Public Healht, Clinical Pharmacology, University of Southern Denmark |
More Information
| Responsible Party: | Institute of Pyblic Health, Clinical Pharmacology, University of Soutern Denmark ( Professor, M.D. Kim Brosen ) |
| Study ID Numbers: | AKF-372, EudraCT: 2007-004470-10 |
| Study First Received: | June 3, 2008 |
| Last Updated: | September 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00692263 |
| Health Authority: | Denmark: Danish Dataprotection Agency; Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Medicines Agency |
|
Healthy subjects |
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Tramadol Healthy Dexetimide Citalopram Serotonin |
|
Parasympatholytics Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents Sensory System Agents Therapeutic Uses Analgesics |
Antidepressive Agents, Second-Generation Antidepressive Agents Analgesics, Opioid Central Nervous System Depressants Narcotics Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |
