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| Sponsor: | University of Southern Denmark |
|---|---|
| Collaborator: |
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 History of Changes |
| Health Authority: | Denmark: Danish Dataprotection Agency; Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Medicines Agency |
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Healthy subjects |
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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 Dexetimide |
Antidepressive Agents, Second-Generation Antidepressive Agents Analgesics, Opioid Tramadol Central Nervous System Depressants Narcotics Citalopram Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |
