The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects
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ClinicalTrials.gov Identifier: NCT00692263 |
Recruitment Status :
Completed
First Posted : June 6, 2008
Last Update Posted : September 10, 2008
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: escitalopram and tramadol Drug: placebo Drug: placebo and tramadol | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects |
Study Start Date : | February 2008 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | August 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: A
Escitalopram - tramadol
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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:
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Experimental: B
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
Other Names:
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Experimental: C
placebo - placebo
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Drug: placebo
placebo identical for 10 mg/ 20 mg escitalopram and 150 mg tramadol |
- AUC of (+)-M1 metabolite of tramadol [ Time Frame: 24 hours ]
- Dynamic pupillometry [ Time Frame: 24 hours ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy
- Age: 18 - 45 years
- CYP2D6 phenotyped as extensive metabolizer
- CYP2C19 phenotyped as extensive metabolizer
Exclusion Criteria:
- Alcohol or drug abuse

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): NCT00692263
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 |
Responsible Party: | Professor, M.D. Kim Brosen, Institute of Pyblic Health, Clinical Pharmacology, University of Soutern Denmark |
ClinicalTrials.gov Identifier: | NCT00692263 |
Other Study ID Numbers: |
AKF-372 EudraCT: 2007-004470-10 |
First Posted: | June 6, 2008 Key Record Dates |
Last Update Posted: | September 10, 2008 |
Last Verified: | September 2008 |
Healthy subjects |
Tramadol Citalopram Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs |
Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Peripheral Nervous System Agents Analgesics, Opioid Narcotics Central Nervous System Depressants Analgesics Sensory System Agents |