The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects
This study has been completed.
Sponsor:
University of Southern Denmark
Collaborator:
H. Lundbeck A/S
Information provided by:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT00692263
First received: June 3, 2008
Last updated: September 9, 2008
Last verified: September 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects |
Resource links provided by NLM:
Further study details as provided by University of Southern Denmark:
Primary Outcome Measures:
- AUC of (+)-M1 metabolite of tramadol [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Dynamic pupillometry [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Experimental: A
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
Other Names:
|
|
Experimental: B
Placebo - tramadol
|
Drug: placebo and tramadol
9 days of placebo equivalent to 10 / 20 mg escitalopram, one single dose of 150 mg tramadol on day 9
Other Names:
|
|
Experimental: C
placebo - placebo
|
Drug: placebo
placebo identical for 10 mg/ 20 mg escitalopram and 150 mg tramadol
Other Name: placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy
- Age: 18 - 45 years
- CYP2D6 phenotyped as extensive metabolizer
- CYP2C19 phenotyped as extensive metabolizer
Exclusion Criteria:
- Alcohol or drug abuse
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692263
Locations
| Denmark | |
| Institute of Public Health, Clinical Pharmacology, University of Southern Denmark | |
| Odense, Denmark, DK-5000 | |
Sponsors and Collaborators
University of Southern Denmark
H. Lundbeck A/S
Investigators
| Study Chair: | Kim Brosen, MD, D.Sc | Institute of Public Healht, Clinical Pharmacology, University of Southern Denmark |
More Information
No publications provided
| Responsible Party: | Professor, M.D. Kim Brosen, Institute of Pyblic Health, Clinical Pharmacology, University of Soutern Denmark |
| ClinicalTrials.gov Identifier: | NCT00692263 History of Changes |
| Other Study ID Numbers: | AKF-372, EudraCT: 2007-004470-10 |
| Study First Received: | June 3, 2008 |
| Last Updated: | September 9, 2008 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: The Regional Committee on Biomedical Research Ethics Denmark: Danish Medicines Agency |
Keywords provided by University of Southern Denmark:
|
Healthy subjects |
Additional relevant MeSH terms:
|
Dexetimide Citalopram Tramadol Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists |
Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents Narcotics Central Nervous System Depressants Analgesics Sensory System Agents Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 16, 2013