The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects
NCT ID: NCT00692263
Last Updated: 2008-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
15 participants
INTERVENTIONAL
2008-02-29
2008-08-31
Brief Summary
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It is stated that escitalopram is only a weak inhibitor of CYP2D6 and therefore no effect is seen in Pk or PK of tramadol
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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A
Escitalopram - tramadol
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
B
Placebo - tramadol
placebo and tramadol
9 days of placebo equivalent to 10 / 20 mg escitalopram, one single dose of 150 mg tramadol on day 9
C
placebo - placebo
placebo
placebo identical for 10 mg/ 20 mg escitalopram and 150 mg tramadol
Interventions
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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
placebo
placebo identical for 10 mg/ 20 mg escitalopram and 150 mg tramadol
placebo and tramadol
9 days of placebo equivalent to 10 / 20 mg escitalopram, one single dose of 150 mg tramadol on day 9
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age: 18 - 45 years
* CYP2D6 phenotyped as extensive metabolizer
* CYP2C19 phenotyped as extensive metabolizer
Exclusion Criteria
18 Years
45 Years
ALL
Yes
Sponsors
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H. Lundbeck A/S
INDUSTRY
University of Southern Denmark
OTHER
Responsible Party
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Institute of Pyblic Health, Clinical Pharmacology, University of Soutern Denmark
Principal Investigators
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Kim Brosen, MD, D.Sc
Role: STUDY_CHAIR
Institute of Public Healht, Clinical Pharmacology, University of Southern Denmark
Locations
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Institute of Public Health, Clinical Pharmacology, University of Southern Denmark
Odense, , Denmark
Countries
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Other Identifiers
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EudraCT: 2007-004470-10
Identifier Type: -
Identifier Source: secondary_id
AKF-372
Identifier Type: -
Identifier Source: org_study_id
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