NCT00361790CompletedPhase 1
Effects on Aripiprazole on the Steady-State Pharmacokinetics of Escitalopram in Healthy Subjects
Otsuka Pharmaceutical Development & Commercialization, Inc.1 site in 1 country25 target enrollmentStarted: August 1, 2006Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Multiple dose PK parameters for Lexapro when administered alone and coadministered with aripiprazole will be derived. Cmin for aripiprazole,dehydro-aripiprazole will be measured
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male and female subjects, ages 18 to
- •(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.
Arms & Interventions
1
Other
Intervention: 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 (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Safety will be based on review of AEs, VS, ECGs, physical exam, clinical labs
Investigators
Study Sites (1)
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