Aripiprazole and Lexapro Drug Interaction Study
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...
Brief Summary
Official Title: “Effects on Aripiprazole on the Steady-State Pharmacokinetics of Escitalopram in Healthy Subjects”
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.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
- Study Primary Completion Date: November 2006
Intervention(s) in this Clinical Trial
- 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.
Arms, Groups and Cohorts in this Clinical Trial
- Other: 1
Outcome Measures for this Clinical Trial
Primary Measures
- Multiple dose PK parameters for Lexapro when administered alone and coadministered with aripiprazole will be derived. Cmin for aripiprazole,dehydro-aripiprazole will be measured
Secondary Measures
- Safety will be based on review of AEs, VS, ECGs, physical exam, clinical labs
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Healthy male and female subjects, ages 18 to 45. (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy in minimized.
- Body Mass Index (BMI) of 18 to 33 kg/m2 inclusive.
Exclusion Criteria:
- Subjects with a decrease in SBP of >=20 mm Hg and increase in HR of >=20 bpm after 2 minutes standing vs. 2 minutes supine at screening or with frank orthostatic hypotension at screening.
- Supine BP of 90/50 mm Hg or lower at screening.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 45 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: Bristol-Myers Squibb Industry
Overall Clinical Trial Officials and Contacts
Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00361790
Study ID Number: CN138-463 ST
ClinicalTrials.gov Identifier: NCT00361790
Health Authority: United States: Food and Drug Administration
BMS Clinical Trials Disclosure
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00361790
