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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00361790 |
Purpose
The purpose of this clinical research study is to learn whether aripiprazole has effect on the steady-state pharmacokinetics of escitalopram in healthy subjects. The safety and tolerability of aripiprazole and escitalopram co-administration will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Escitalopram on days -7 to day 14; Aripiprazole dosed starting Day 1 to day 14: 3 days at 10 mg, 4 days at 15 mg and 7 days at 20 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | Effects on Aripiprazole on the Steady-State Pharmacokinetics of Escitalopram in Healthy Subjects |
| Estimated Enrollment: | 25 |
| Study Start Date: | August 2006 |
| Arms | Assigned Interventions |
|---|---|
| 1 |
Drug: Escitalopram on days -7 to day 14; Aripiprazole dosed starting Day 1 to day 14: 3 days at 10 mg, 4 days at 15 mg and 7 days at 20 mg
Tablets, Oral, Escitalopram: 10 mg; Aripiprazole: 10, 15, 20 mg, once daily, 14 days.
|
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
More Information
| Study ID Numbers: | CN138-463 ST |
| Study First Received: | August 7, 2006 |
| Last Updated: | June 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00361790 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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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 Therapeutic Uses Aripiprazole Dexetimide |
Antidepressive Agents, Second-Generation Antidepressive Agents Tranquilizing Agents Central Nervous System Depressants Antipsychotic Agents Citalopram Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |